PROTECTIF UNTINTED- zinc oxide and titanium dioxide cream 
Derma Research Group Inc.

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.

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Drug Facts

Active Ingredients

Zinc Oxide 8.6 %

Titanium Dioxide 6.5 %

Purpose

Sun Protectant

Uses

Helps Prevent sunburn

Warning

For external use only.

Do not use

Do not use on damaged or broken skin

When using

When using this product, avoid contect with eyes.If contect occurs, rinse throughly with water.

stop use

Discontinue use if rash or irritation develops or lasts. If irritation persists,consultant a doctor

Keep out of reach of children

If swallowed get medical help or contect poison control center right away

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.

NA

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

Protectif untinted

PROTECTIF UNTINTED 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82038-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82038-004-021 in 1 CARTON06/22/2022
1NDC:82038-004-01100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02006/22/2022
Labeler - Derma Research Group Inc. (200108372)

Revised: 6/2022
Document Id: e273cc47-7609-7f72-e053-2a95a90acdc5
Set id: e273ccfc-3b2e-fdf4-e053-2a95a90ae4a3
Version: 1
Effective Time: 20220627
 
Derma Research Group Inc.