Label: PROTECTIF FAIR TINT- zinc oxide and titanium dioxide cream
- NDC Code(s): 82038-006-01, 82038-006-02, 82038-006-03, 82038-006-04
- Packager: Derma Research Group Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 18, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions: Adults and Children over 6 months of age: Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 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 take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses.
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OTHER SAFETY INFORMATION
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 take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses.
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INACTIVE INGREDIENT
Inactive Ingredients: Water (Aqua), Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polysilicone-31, Glycerin, Aluminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Dipropylene Glycol, Sodium Citrate, Tocopherol, Dimethicone/Polyglycerin-3 Crosspolymer, Dimethicone / Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Cetearyl Olivate, Sorbitan Olivate, Benzoic Acid, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Pentylene Glycol, Sodium Hyaluronate, Cyclohexasiloxane, PEG-8, Ascorbyl Palmitate, Ascorbic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Ferrocyanide Decahydrate, Hydroxytyrosol, Polygonum Aviculare Extract, Sodium Benzoate, Potassium Sorbate, Alcohol, Lecithin, Ectoin, Cyclotetra peptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Camellia Sinensis Leaf Extract, Coffee Arabica (Coffee) Seed Extract, Citric Acid, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Triethoxycaprylylsilane, Iron Oxides(CI 77491, CI 77492, CI 77499)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROTECTIF FAIR TINT
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82038-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8.6 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.5 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) PENTYLENE GLYCOL (UNII: 50C1307PZG) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) HEXYL LAURATE (UNII: 4CG9F9W01Q) CETEARYL OLIVATE (UNII: 58B69Q84JO) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) DIMETHICONE (UNII: 92RU3N3Y1O) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SODIUM FERROCYANIDE DECAHYDRATE (UNII: CG0CLR485X) PHENOXYETHANOL (UNII: HIE492ZZ3T) APPLE (UNII: B423VGH5S9) SODIUM CHLORIDE (UNII: 451W47IQ8X) TOCOPHEROL (UNII: R0ZB2556P8) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) DIPROPYLENE GLYCOL (UNII: E107L85C40) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) POLYSORBATE 20 (UNII: 7T1F30V5YH) CYCLOMETHICONE 4 (UNII: CZ227117JE) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) SODIUM CITRATE (UNII: 1Q73Q2JULR) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ASCORBYL PALMITATE (UNII: QN83US2B0N) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SODIUM BENZOATE (UNII: OJ245FE5EU) ALCOHOL (UNII: 3K9958V90M) CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE (UNII: NR327745KQ) HYDROXYTYROSOL (UNII: QEU0NE4O90) WINE GRAPE (UNII: 3GOV20705G) ISOMALT (UNII: S870P55O2W) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ARABICA COFFEE BEAN (UNII: 3SW678MX72) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) ECTOINE (UNII: 7GXZ3858RY) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) SORBITAN OLIVATE (UNII: MDL271E3GR) BENZOIC ACID (UNII: 8SKN0B0MIM) ETHYLHEXYL PALMITATE (UNII: 2865993309) ASCORBIC ACID (UNII: PQ6CK8PD0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82038-006-02 1 in 1 CARTON 05/10/2024 1 NDC:82038-006-01 100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:82038-006-04 1 in 1 CARTON 05/10/2024 2 NDC:82038-006-03 30 g 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 Drug M020 05/10/2024 Labeler - Derma Research Group Inc. (200108372)