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

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Drug Facts

Active Ingredients: Zinc Oxide 8.6%, Titanium Dioxide 6.5%

Purpose: Sun Protectant

Uses: Broad spectrum (Sun Protection Factor 50 /SPF 50).

Warning: For external use only.

Do not use on damaged or broken skin.

When using this product avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

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

Keep out of reach of Children -if swallowed get medical help or contact Poison Control Center right away.

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

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

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-1011 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 Deca hydrate, Hydroxytyrosol, Polygonum Aviculare Extract, Sodium Benzoate, Potassium Sorbate, Alcohol, Lecithin, Ectoin, Cyclotetra peptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetra peptide-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

Protectif Untinted

PROTECTIF UNTINTED 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82038-007
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
TOCOPHEROL (UNII: R0ZB2556P8)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
HYDROXYTYROSOL (UNII: QEU0NE4O90)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
SODIUM FERROCYANIDE DECAHYDRATE (UNII: CG0CLR485X)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE (UNII: NR327745KQ)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
WINE GRAPE (UNII: 3GOV20705G)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
APPLE (UNII: B423VGH5S9)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ECTOINE (UNII: 7GXZ3858RY)  
ISOMALT (UNII: S870P55O2W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82038-007-021 in 1 CARTON05/17/2024
1NDC:82038-007-01100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:82038-007-041 in 1 CARTON05/17/2024
2NDC:82038-007-0330 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/17/2024
Labeler - Derma Research Group Inc. (200108372)

Revised: 6/2024
Document Id: 1acd3232-7d83-8f27-e063-6294a90a0fb4
Set id: 1acd3f09-87f2-75e4-e063-6394a90a0cd9
Version: 1
Effective Time: 20240613
 
Derma Research Group Inc.