Label: PROTECTIF DEEP TINT- zinc oxide and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 82038-002-01, 82038-002-02 - Packager: Derma Research Group 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 25, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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: Apply 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 other sun protection measures including limit time in the sun especially from 10 am to 2 pm wear long sleeve shirts pants hats and sunglasses
- OTHER SAFETY INFORMATION
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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 Hydroxyhydrocinna mate, 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:82038-002 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 DIPROPYLENE GLYCOL (UNII: E107L85C40) APPLE (UNII: B423VGH5S9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE (UNII: NR327745KQ) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FERROSOFERRIC OXIDE (UNII: XM0M87F357) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) ALCOHOL (UNII: 3K9958V90M) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN OLIVATE (UNII: MDL271E3GR) ISOMALT (UNII: S870P55O2W) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ARABICA COFFEE BEAN (UNII: 3SW678MX72) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 4 (UNII: CZ227117JE) HYDROXYTYROSOL (UNII: QEU0NE4O90) BENZOIC ACID (UNII: 8SKN0B0MIM) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CYCLOMETHICONE 6 (UNII: XHK3U310BA) ASCORBYL PALMITATE (UNII: QN83US2B0N) SODIUM FERROCYANIDE DECAHYDRATE (UNII: CG0CLR485X) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CETEARYL OLIVATE (UNII: 58B69Q84JO) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) ECTOINE (UNII: 7GXZ3858RY) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM CITRATE (UNII: 1Q73Q2JULR) DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9) ETHYLHEXYL PALMITATE (UNII: 2865993309) PENTYLENE GLYCOL (UNII: 50C1307PZG) HEXYLENE GLYCOL (UNII: KEH0A3F75J) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) ASCORBIC ACID (UNII: PQ6CK8PD0R) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) SODIUM BENZOATE (UNII: OJ245FE5EU) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) VITIS VINIFERA STEM (UNII: K1Z31TDY7Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) TOCOPHEROL (UNII: R0ZB2556P8) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82038-002-02 1 in 1 CARTON 06/21/2022 1 NDC:82038-002-01 100 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 06/21/2022 Labeler - Derma Research Group Inc. (200108372)
