Label: ZO SKIN HEALTH DAILY SKINCARE PROGRAM- titanium dioxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 42851-166-15 - Packager: ZO Skin Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- 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
- reapply at least every 2 hours
- children under 6 months of age: Ask a doctor
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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
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH DAILY SKINCARE PROGRAM
titanium dioxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-166 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-166-15 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 60 Part 4 1 BOTTLE, PUMP 30 mL Part 5 1 BOTTLE, PUMP 15 mL Part 1 of 5 ZO SKIN HEALTH EXFOLIATING CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) gelProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) INGR COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR POWDERED CELLULOSE (UNII: SMD1X3XO9M) INGR MANNITOL (UNII: 3OWL53L36A) INGR CAPRYLIC ALCOHOL (UNII: NV1779205D) INGR NIACIN (UNII: 2679MF687A) INGR AMMONIUM LACTATE (UNII: 67M901L9NQ) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R) 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 5 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 5 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 60 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 5 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 5 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB 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(42851-166) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 manufacture(42851-166) Establishment Name Address ID/FEI Business Operations DIAMOND WIPES INTERNATIONAL, INC. 161104729 manufacture(42851-166) Establishment Name Address ID/FEI Business Operations PakLab 790530976 manufacture(42851-166)
