Label: SHEER TINT SPF20 - LIGHT- zinc oxide and octinoxate lotion
SHEER TINT SPF20 - MEDIUM- zinc oxide and octinoxate lotion
SHEER TINT SPF20 - DARK- zinc oxide and octinoxate lotion

  • 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 December 4, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate 4.5%,
    Zinc Oxide 9.5%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn.
    • if used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

    Do not use

    • on damaged or broken skin

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a Doctor

    • if rash occurs

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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
    • Children under 6 months: ask a doctor
  • Other information

    • Protect this product from excessive heat and direct sun
  • Inactive ingredients

    Water/Aqua, Caprylic/Capric Triglyceride, Dimethicone, Dimethyl Isosorbide, Methyl Gluceth-20, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Cetearyl Alcohol, Hydrolyzed Pearl, Juglans Regia (Walnut) Seed Extract, Sodium Hyaluronate Crosspolymer, Silanetriol, Lavandula Spica (Lavender) Flower Oil, Lavandula Hybrida Oil, Eucalyptus Globulus Leaf Oil, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolmer, Polyhydroxystearic Acid, Squalane, Triethoxycaprylylsilane, Polysorbate 60, Cetyl Alcohol, Silica Dimethyl Silylate, Magnesium Aluminum Silicate, Pentylene Glycol, Ethylhexylglycerin, Disodium EDTA, Silica, Phenoxyethanol, Tin Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

  • Questions?

    1-800-831-5150 in USA

  • PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Light

    sheer
    tint

    spf
    20

    broad
    spectrum

    light

    1.3 US FL OZ / 40 mL e

    dermalogica®

    PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Light
  • PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Medium

    sheer
    tint

    spf
    20

    broad
    spectrum

    medium

    1.3 US FL OZ / 40 mL e

    dermalogica®

    PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Medium
  • PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Dark

    sheer
    tint

    spf
    20

    broad
    spectrum

    dark

    1.3 US FL OZ / 40 mL e

    dermalogica®

    PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Dark
  • INGREDIENTS AND APPEARANCE
    SHEER TINT   SPF20 - LIGHT
    zinc oxide and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide95 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dimethyl Isosorbide (UNII: SA6A6V432S)  
    Methyl Gluceth-20 (UNII: J3QD0LD11P)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    English Walnut (UNII: 1V3SHR7QB7)  
    PEG-9 Diglycidyl Ether/Sodium Hyaluronate Crosspolymer (UNII: 788QAG3W8A)  
    Silanetriol (UNII: E52D0J3TS5)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)  
    Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
    Squalane (UNII: GW89575KF9)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Silica Dimethyl Silylate (UNII: EU2PSP0G0W)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Stannic Oxide (UNII: KM7N50LOS6)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWN (Skin Tone Light) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-201-021 in 1 CARTON01/22/2015
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-201-002 mL in 1 POUCH; Type 0: Not a Combination Product01/22/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/22/2015
    SHEER TINT   SPF20 - MEDIUM
    zinc oxide and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide95 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dimethyl Isosorbide (UNII: SA6A6V432S)  
    Methyl Gluceth-20 (UNII: J3QD0LD11P)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    English Walnut (UNII: 1V3SHR7QB7)  
    PEG-9 Diglycidyl Ether/Sodium Hyaluronate Crosspolymer (UNII: 788QAG3W8A)  
    Silanetriol (UNII: E52D0J3TS5)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)  
    Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
    Squalane (UNII: GW89575KF9)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Silica Dimethyl Silylate (UNII: EU2PSP0G0W)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Stannic Oxide (UNII: KM7N50LOS6)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWN (Skin Tone Medium) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-901-021 in 1 CARTON01/22/2015
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-901-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2015
    3NDC:68479-901-002 mL in 1 POUCH; Type 0: Not a Combination Product01/22/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/22/2015
    SHEER TINT   SPF20 - DARK
    zinc oxide and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide95 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dimethyl Isosorbide (UNII: SA6A6V432S)  
    Methyl Gluceth-20 (UNII: J3QD0LD11P)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    English Walnut (UNII: 1V3SHR7QB7)  
    PEG-9 Diglycidyl Ether/Sodium Hyaluronate Crosspolymer (UNII: 788QAG3W8A)  
    Silanetriol (UNII: E52D0J3TS5)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)  
    Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
    Squalane (UNII: GW89575KF9)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Silica Dimethyl Silylate (UNII: EU2PSP0G0W)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Stannic Oxide (UNII: KM7N50LOS6)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWN (Skin Tone Dark) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-301-021 in 1 CARTON01/22/2015
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-301-002 mL in 1 POUCH; Type 0: Not a Combination Product01/22/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/22/2015
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway620899877MANUFACTURE(68479-201, 68479-901, 68479-301)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-201, 68479-901, 68479-301)
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