![ZO SKIN HEALTH LEVEL III AGGRESSIVE ANTI-AGING PROGRAM WITH ADVANCED RADICAL NIGHT REPAIR (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]](https://medic.hrt.org//dailymed/images/7548e51e-9438-4664-87cc-e9a70397f00f/anti-aging-01.jpg)
| NDC | 42851-051-01, 42851-154-01 |
| Set ID | 7548e51e-9438-4664-87cc-e9a70397f00f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | ZO Skin Health, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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: 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.
- Apply to all skin exposed to the sun
- Other information
-
Inactive ingredients
Cyclopentasiloxane, Cyclotetrasiloxane,Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone Crosspolymer, Melanin,Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Alumina, Laureth-23, Methicone, PEG-10 Dimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Methylparaben, Myristoyl Pentapeptide-8, Iron Oxide (CI 77492).
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
-
INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH LEVEL III AGGRESSIVE ANTI-AGING PROGRAM WITH ADVANCED RADICAL NIGHT REPAIR
titanium dioxide and zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-154 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-154-01 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 JAR 16.2 g Part 2 1 TUBE 40 mL Part 3 1 JAR 50 mL Part 4 1 BOTTLE, PUMP 30 mL Part 5 1 TUBE, WITH APPLICATOR 30 mL Part 6 1 BOTTLE, PUMP 15 mL Part 1 of 6 OFFECTS EXFOLIATING POLISH ANTI-AGING FORMULA
cleansing (cold creams, cleansing lotions, liquids, and pads) 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 DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INGR MAGNESIUM OXIDE (UNII: 3A3U0GI71G) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR Oleth-20 (UNII: YTH167I2AG) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR TRIHYDROXYSTEARIN (UNII: 06YD7896S3) INGR PEG-100 Stearate (UNII: YD01N1999R) INGR TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR SOY STEROL (UNII: PL360EPO9J) INGR OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) INGR TEA TREE OIL (UNII: VIF565UC2G) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/11/2012 Part 2 of 6 OFFECTS HYDRATING CLEANSER NORMAL TO DRY SKIN ANTI-AGING FORMULA
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 METHYL COCOYL TAURATE (UNII: JVL98CG53G) INGR SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) INGR DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR UREA (UNII: 8W8T17847W) INGR TREHALOSE (UNII: B8WCK70T7I) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR GLYCOL DISTEARATE (UNII: 13W7MDN21W) INGR STEARIC ACID (UNII: 4ELV7Z65AP) INGR ALLANTOIN (UNII: 344S277G0Z) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) INGR METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 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 40 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/11/2012 Part 3 of 6 OMMERSE RENEWAL ANTI-AGING FORMULA
cleansing (cold creams, cleansing lotions, liquids, and pads) 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 Polysorbate 60 (UNII: CAL22UVI4M) INGR EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) INGR JOJOBA BUTTER (UNII: XIA46H803R) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR OAT (UNII: Z6J799EAJK) INGR RETINOL (UNII: G2SH0XKK91) INGR C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ECTOINE (UNII: 7GXZ3858RY) INGR STEARETH-21 (UNII: 53J3F32P58) INGR COCOS NUCIFERA WHOLE (UNII: 245J88W96L) INGR GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR LAURETH-23 (UNII: N72LMW566G) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR STEARETH-2 (UNII: V56DFE46J5) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR EDETATE SODIUM (UNII: MP1J8420LU) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR SOYBEAN OIL (UNII: 241ATL177A) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SOY STEROL (UNII: PL360EPO9J) INGR UBIDECARENONE (UNII: EJ27X76M46) INGR Sodium Chloride (UNII: 451W47IQ8X) INGR Sodium Metabisulfite (UNII: 4VON5FNS3C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/11/2012 Part 4 of 6 OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA
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 PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR RETINOL (UNII: G2SH0XKK91) INGR EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR JOJOBA BUTTER (UNII: XIA46H803R) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR CURDLAN (UNII: 6930DL209R) INGR LACTOSE (UNII: J2B2A4N98G) 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 ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) INGR C14-22 ALCOHOLS (UNII: B1K89384RJ) INGR CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) INGR C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) INGR POWDERED CELLULOSE (UNII: SMD1X3XO9M) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) INGR PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) INGR HYPROMELLOSES (UNII: 3NXW29V3WO) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR LIMONENE, (+/-)- (UNII: 9MC3I34447) 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/11/2012 Part 5 of 6 OSSENTIAL ADVANCED RADICAL NIGHT REPAIR ANTI-AGING FORMULA
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR ALMOND OIL (UNII: 66YXD4DKO9) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR WATER (UNII: 059QF0KO0R) INGR RETINOL (UNII: G2SH0XKK91) INGR CYCLOMETHICONE 4 (UNII: CZ227117JE) INGR DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) INGR PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z) INGR OLEYL ALCOHOL (UNII: 172F2WN8DV) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR SUNFLOWER OIL (UNII: 3W1JG795YI) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR CHLORPHENESIN (UNII: I670DAL4SZ) INGR ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418) INGR SODIUM SULFITE (UNII: VTK01UQK3G) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR GLUCONOLACTONE (UNII: WQ29KQ9POT) INGR BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) INGR ROSEMARY (UNII: IJ67X351P9) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR ASCORBIC ACID (UNII: PQ6CK8PD0R) INGR CORN OIL (UNII: 8470G57WFM) INGR .BETA.-CAROTENE (UNII: 01YAE03M7J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/11/2012 Part 6 of 6 OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION
titanium dioxide and zinc oxide lotionProduct Information Item Code (Source) NDC:42851-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 102 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 37 mg in 1 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) TRIBEHENIN (UNII: 8OC9U7TQZ0) CALCIUM BEHENATE (UNII: J5VFA9V6YG) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) DIMETHICONOL (40 CST) (UNII: 343C7U75XW) ALUMINUM OXIDE (UNII: LMI26O6933) LAURETH-23 (UNII: N72LMW566G) METHICONE (20 CST) (UNII: 6777U11MKT) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-051-01 15 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/11/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/11/2012 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Lifetech Resources 622559110 MANUFACTURE(42851-154) Establishment Name Address ID/FEI Business Operations PakLab 177711082 MANUFACTURE(42851-154) Establishment Name Address ID/FEI Business Operations Thibiant International 083913913 MANUFACTURE(42851-154) Establishment Name Address ID/FEI Business Operations Owen Biosciences 790003045 MANUFACTURE(42851-154)
