![ZO SKIN HEALTH RENEW (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]](https://medic.hrt.org//dailymed/images/3da6948a-d424-40b4-85da-0df8783de580/skinrenew-01.jpg)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- children under 6 months of age: ask a doctor
- reapply at least every two hours
-
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
Cyclopentasiloxane, Dimethicone Crosspolymer, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Stearic Acid, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Tribehenin, Water, Helianthus Annuus (Sunflower) Seed Oil, Polymethyl Methacrylate, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Dimethiconol, Cyclotetrasiloxane, Squalane, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Melanin, Behenyl Behenate, Triethoxycaprylylsilane, Polyglyceryl-5 Trioleate, Ethyl Ferulate, Glycine Soja (Soybean) Seed Extract, Calcium Chloride, Retinyl Palmitate, Pentylene Glycol, Methylisothiazolinone, Ascorbic Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Phenoxyethanol, Potassium Sorbate, Ethylhexylglycerin, Myristoyl Pentapeptide-8, Tocopherol, Disodium Uridine Phosphate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Iron Oxides.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH RENEW
titanium dioxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-163 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-163-01 1 in 1 CARTON 12/01/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 40 mL Part 2 1 JAR 16.2 g Part 3 1 BOTTLE, PUMP 15 mL Part 1 of 3 ZO SKIN HEALTH OFFECTS 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 STEARIC ACID (UNII: 4ELV7Z65AP) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR GLYCOL DISTEARATE (UNII: 13W7MDN21W) INGR DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR UREA (UNII: 8W8T17847W) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR TREHALOSE (UNII: B8WCK70T7I) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR SODIUM GLYCOLATE (UNII: B75E535IMI) INGR TRIACETIN (UNII: XHX3C3X673) INGR CHLORPHENESIN (UNII: I670DAL4SZ) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR SORBIC ACID (UNII: X045WJ989B) INGR POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) INGR ALLANTOIN (UNII: 344S277G0Z) 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; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 12/01/2015 Part 2 of 3 ZO SKIN HEALTH OFFECTS EXFOLIATING POLISH
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 .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR TEA TREE OIL (UNII: VIF565UC2G) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 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 12/01/2015 Part 3 of 3 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION
titanium dioxide lotionProduct Information Item Code (Source) NDC:42851-053 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 CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TRIBEHENIN (UNII: 8OC9U7TQZ0) WATER (UNII: 059QF0KO0R) SUNFLOWER OIL (UNII: 3W1JG795YI) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) CYCLOMETHICONE 4 (UNII: CZ227117JE) SQUALANE (UNII: GW89575KF9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) BEHENYL BEHENATE (UNII: K8NU647RJ0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ETHYL FERULATE (UNII: 5B8915UELW) SOYBEAN (UNII: L7HT8F1ZOD) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PENTYLENE GLYCOL (UNII: 50C1307PZG) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ASCORBIC ACID (UNII: PQ6CK8PD0R) ROSEMARY (UNII: IJ67X351P9) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-053-01 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 12/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/01/2015 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Lifetech Resources, LLC. 081239587 manufacture(42851-163) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 manufacture(42851-163)
