Label: PROTECTIF UNTINTED- zinc oxide and titanium dioxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 82038-004-01, 82038-004-02 - 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 27, 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
-
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 a.m. - 2 p.m., wear long-sleeve shirts, pants, hats and sunglasses.
- OTHER SAFETY INFORMATION
-
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, DimethiconelPolyglycerin-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,Sornitan 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,VitisVinifera(Grape)Fruit Cell Extract,Isomalt,Camellia Sinensis Leaf Extract,
Coffea Arabica (Coffee) Seed Extract,Citric Acid, Phenoxyethanol,Caprylyl Glycol,Ethylhexylglycerin,Hexylene Glycol
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PROTECTIF UNTINTED
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82038-004 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 PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PENTYLENE GLYCOL (UNII: 50C1307PZG) ALCOHOL (UNII: 3K9958V90M) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) SORBITAN OLIVATE (UNII: MDL271E3GR) ASCORBYL PALMITATE (UNII: QN83US2B0N) APPLE (UNII: B423VGH5S9) SODIUM CHLORIDE (UNII: 451W47IQ8X) HEXYL LAURATE (UNII: 4CG9F9W01Q) CETEARYL OLIVATE (UNII: 58B69Q84JO) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM FERROCYANIDE DECAHYDRATE (UNII: CG0CLR485X) SODIUM BENZOATE (UNII: OJ245FE5EU) HYDROXYTYROSOL (UNII: QEU0NE4O90) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ISOMALT (UNII: S870P55O2W) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ARABICA COFFEE BEAN (UNII: 3SW678MX72) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9) HEXYLENE GLYCOL (UNII: KEH0A3F75J) BENZOIC ACID (UNII: 8SKN0B0MIM) ETHYLHEXYL PALMITATE (UNII: 2865993309) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) CYCLOMETHICONE 4 (UNII: CZ227117JE) CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE (UNII: NR327745KQ) VITIS VINIFERA STEM (UNII: K1Z31TDY7Z) ECTOINE (UNII: 7GXZ3858RY) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82038-004-02 1 in 1 CARTON 06/22/2022 1 NDC:82038-004-01 100 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 06/22/2022 Labeler - Derma Research Group Inc. (200108372)
