PROTECTIF DEEP TINT- 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-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)

Protectif Deep Tint

PROTECTIF DEEP TINT 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82038-005
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82038-005-021 in 1 CARTON05/09/2024
1NDC:82038-005-01100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:82038-005-041 in 1 CARTON05/09/2024
2NDC:82038-005-0330 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 DrugM02005/09/2024
Labeler - Derma Research Group Inc. (200108372)

Revised: 5/2024
Document Id: 19b18cbb-b098-266a-e063-6294a90a81a8
Set id: 19b19023-1340-6609-e063-6394a90a6eaf
Version: 1
Effective Time: 20240530
 
Derma Research Group Inc.