![ZO SKIN HEALTH AGGRESSIVE ANTI-AGING PROGRAM (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]](https://medic.hrt.org//dailymed/images/09c44e81-6aa8-41e9-8624-041aab40093d/zoskin-01.jpg)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
Uses
- helps prevent sunburn.
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months of age: Ask a doctor
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.- 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
- Other information
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Inactive ingredients
Aluminum Hydroxide, Aqua/Water/Eau, Ascorbic Acid, Behenyl Behenate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium Uridine Phosphate, Ethyl Ferulate, Ethylhexylglycerin, Glycerin, Glycine Soja Extract, Helianthus Annuus Seed Oil, Hexyl Laurate, Iron Oxides, Melanin, Myristoyl Pentapeptide-8, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Pentylene Glycol, Phenoxyethanol, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polyglyceryl-4 Isostearate, Polyglyceryl-5 Trioleate, Polymethyl Methacrylate, Retinyl Palmitate, Rosmarinus Officinalis Leaf Extract, Squalane, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Triethoxycaprylylsilane.
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - Kit Carton
ZO ® SKIN HEALTH
BY ZEIN OBAGI MDAGGRESSIVE ANTI-AGING PROGRAM
NDC 42851-168-15HYDRATING CLEANSER 60 mL / 2 Fl. Oz. EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.
COMPLEXION RENEWAL PADS 30 Pads DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.
ADVANCED RADICAL NIGHT REPAIR 30 mL / 1 Fl. Oz. RENEWAL CRÈME 50 mL / 1.7 Fl. Oz.
SUNSCREEN + PRIMER SPF 30 15 mL / 0.5 Fl. Oz.
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH AGGRESSIVE ANTI-AGING PROGRAM
titanium dioxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-168 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-168-15 1 in 1 CARTON 11/01/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 60 mL Part 2 1 JAR 16.2 g Part 3 1 BOTTLE, GLASS 30 Part 4 1 BOTTLE, PUMP 30 mL Part 5 1 TUBE, WITH APPLICATOR 30 mL Part 6 1 JAR 50 mL Part 7 1 BOTTLE, PUMP 15 mL Part 1 of 7 ZO SKIN HEALTH HYDRATING CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) INGR SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR STEARIC ACID (UNII: 4ELV7Z65AP) INGR DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) INGR GLYCOL DISTEARATE (UNII: 13W7MDN21W) INGR PALMITIC ACID (UNII: 2V16EO95H1) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR UREA (UNII: 8W8T17847W) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR TREHALOSE (UNII: B8WCK70T7I) INGR POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) INGR TRIACETIN (UNII: XHX3C3X673) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR ALLANTOIN (UNII: 344S277G0Z) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR D&C RED NO. 33 (UNII: 9DBA0SBB0L) INGR FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 60 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/01/2017 Part 2 of 7 ZO SKIN HEALTH EXFOLIATING POLISH
lotions, oils, powders, and creams creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) INGR SODIUM BICARBONATE (UNII: 8MDF5V39QO) INGR MAGNESIUM OXIDE (UNII: 3A3U0GI71G) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR OLETH-20 (UNII: YTH167I2AG) INGR TRIHYDROXYSTEARIN (UNII: 06YD7896S3) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR MINERAL OIL (UNII: T5L8T28FGP) INGR WATER (UNII: 059QF0KO0R) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR TEA TREE OIL (UNII: VIF565UC2G) INGR SOY STEROL (UNII: PL360EPO9J) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) INGR TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR D&C GREEN NO. 6 (UNII: 4QP5U84YF7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 16.2 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/01/2017 Part 3 of 7 ZO SKIN HEALTH COMPLEXION RENEWAL PADS
cleansing (cold creams, cleansing lotions, liquids, and pads) patchProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR UREA (UNII: 8W8T17847W) INGR GLYCOLIC ACID (UNII: 0WT12SX38S) INGR PTEROCARPUS SOYAUXII WOOD (UNII: 0V6QB4C61P) INGR PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) INGR BARLEY (UNII: 5PWM7YLI7R) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) INGR PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8) INGR CRITHMUM MARITIMUM (UNII: J7IHY79BKY) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) INGR ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/01/2017 Part 4 of 7 ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR CETEARYL ISONONANOATE (UNII: P5O01U99NI) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR CYCLOMETHICONE 6 (UNII: XHK3U310BA) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR C14-22 ALCOHOLS (UNII: B1K89384RJ) INGR CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) INGR SAFFLOWER OIL (UNII: 65UEH262IS) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) INGR LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) INGR POWDERED CELLULOSE (UNII: SMD1X3XO9M) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR RETINOL (UNII: G2SH0XKK91) INGR 1,2-HEXANEDIOL (UNII: TR046Y3K1G) INGR HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) INGR ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) INGR ORANGE OIL (UNII: AKN3KSD11B) INGR MANDARIN OIL (UNII: NJO720F72R) INGR LEMON OIL (UNII: I9GRO824LL) INGR PEPPERMINT OIL (UNII: AV092KU4JH) INGR MIMOSA TENUIFLORA BARK (UNII: 515MQE449I) INGR TANGERINE (UNII: KH3E3096OO) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR FARNESOL (UNII: EB41QIU6JL) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) INGR PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ULTRAMARINE BLUE (UNII: I39WR998BI) INGR EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/01/2017 Part 5 of 7 ZO SKIN HEALTH OSSENTIAL ADVANCED RADICAL NIGHT REPAIR
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR RETINOL (UNII: G2SH0XKK91) INGR DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR SODIUM SULFITE (UNII: VTK01UQK3G) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR ASCORBIC ACID (UNII: PQ6CK8PD0R) INGR PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z) INGR SUNFLOWER OIL (UNII: 3W1JG795YI) INGR ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418) INGR ROSEMARY (UNII: IJ67X351P9) INGR CORN OIL (UNII: 8470G57WFM) INGR .BETA.-CAROTENE (UNII: 01YAE03M7J) INGR CITRAL (UNII: T7EU0O9VPP) INGR GERANIOL (UNII: L837108USY) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/01/2017 Part 6 of 7 ZO SKIN HEALTH OMMERSE RENEWAL CREME
lotions, oils, powders, and creams creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) INGR ISOCETYL STEARATE (UNII: 3RJ7186O9W) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR ECTOINE (UNII: 7GXZ3858RY) INGR STEARETH-21 (UNII: 53J3F32P58) INGR LAURETH-23 (UNII: N72LMW566G) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR STEARETH-2 (UNII: V56DFE46J5) INGR EDETATE SODIUM (UNII: MP1J8420LU) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR RETINOL (UNII: G2SH0XKK91) INGR COCONUT OIL (UNII: Q9L0O73W7L) INGR HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR OAT (UNII: Z6J799EAJK) INGR GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y) INGR MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) INGR UBIDECARENONE (UNII: EJ27X76M46) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 50 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/01/2017 Part 7 of 7 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVAUVB PROTECTION
titanium dioxide lotionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 82 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) BEHENYL BEHENATE (UNII: K8NU647RJ0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) CHLORPHENESIN (UNII: I670DAL4SZ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T) ETHYL FERULATE (UNII: 5B8915UELW) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) HEXYL LAURATE (UNII: 4CG9F9W01Q) FERRIC OXIDE RED (UNII: 1K09F3G675) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ROSEMARY (UNII: IJ67X351P9) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIBEHENIN (UNII: 8OC9U7TQZ0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/01/2017 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Lifetech Resources, LLC. 081239587 manufacture(42851-168) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 manufacture(42851-168) Establishment Name Address ID/FEI Business Operations DIAMOND WIPES INTERNATIONAL INC 161104729 manufacture(42851-168) Establishment Name Address ID/FEI Business Operations PakLab 790530976 manufacture(42851-168)