Label: PROTECTIF DEEP TINT- zinc oxide and titanium dioxide cream

  • NDC Code(s): 82038-005-01, 82038-005-02, 82038-005-03, 82038-005-04
  • Packager: Derma Research Group Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 30, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide 8.6%,

    Titanium Dioxide 6.5%

  • PURPOSE

    Purpose: Sun Protectant

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warning: For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

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

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    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.

  • OTHER SAFETY INFORMATION

    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 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-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)

  • PRINCIPAL DISPLAY PANEL

    Protectif Deep Tint

  • INGREDIENTS AND APPEARANCE
    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)