Label: PROTECTIF DEEP TINT- zinc oxide and titanium dioxide cream
- NDC Code(s): 82038-005-01, 82038-005-02, 82038-005-03, 82038-005-04
- Packager: Derma Research Group Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 30, 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-tbutyl 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, Cyclotetrapeptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Camellia Sinensis Leaf Extract, Coffea 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 DEEP TINT
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82038-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8.6 g in 100 g Inactive Ingredients Ingredient Name Strength VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) ASCORBYL PALMITATE (UNII: QN83US2B0N) ALCOHOL (UNII: 3K9958V90M) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CETEARYL OLIVATE (UNII: 58B69Q84JO) ETHYLHEXYL PALMITATE (UNII: 2865993309) HYDROXYTYROSOL (UNII: QEU0NE4O90) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) ISOMALT (UNII: S870P55O2W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ARABICA COFFEE BEAN (UNII: 3SW678MX72) STEARIC ACID (UNII: 4ELV7Z65AP) BENZOIC ACID (UNII: 8SKN0B0MIM) PENTYLENE GLYCOL (UNII: 50C1307PZG) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) GLYCERIN (UNII: PDC6A3C0OX) HEXYL LAURATE (UNII: 4CG9F9W01Q) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) ECTOINE (UNII: 7GXZ3858RY) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GREEN TEA LEAF (UNII: W2ZU1RY8B0) FERRIC OXIDE RED (UNII: 1K09F3G675) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SODIUM FERROCYANIDE DECAHYDRATE (UNII: CG0CLR485X) POLYSORBATE 20 (UNII: 7T1F30V5YH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9) HEXYLENE GLYCOL (UNII: KEH0A3F75J) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) APPLE (UNII: B423VGH5S9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) TOCOPHEROL (UNII: R0ZB2556P8) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) WINE GRAPE (UNII: 3GOV20705G) SODIUM BENZOATE (UNII: OJ245FE5EU) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM CITRATE (UNII: 1Q73Q2JULR) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SORBITAN OLIVATE (UNII: MDL271E3GR) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ASCORBIC ACID (UNII: PQ6CK8PD0R) CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE (UNII: NR327745KQ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82038-005-02 1 in 1 CARTON 05/09/2024 1 NDC:82038-005-01 100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:82038-005-04 1 in 1 CARTON 05/09/2024 2 NDC:82038-005-03 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 05/09/2024 Labeler - Derma Research Group Inc. (200108372)