Label: B.TAN SUN SAFE AF FACE SPF 70- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 73978-004-01
  • Packager: Marque of Brands Americas, LLC
  • 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 February 4, 2021

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  • ACTIVE INGREDIENT

    Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    • Helps prevent sunburn
    • If used as directed with other sun protection measures, ( see Directions) decreases 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 immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • Apple liberally 15 minutes before sun exposure.
    • Reapply: after 80 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months of age: ask a doctor.
    • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10am-2pm
    • Wear long-sleeved shirts, pants, hats and sunglasses.
  • OTHER SAFETY INFORMATION

    Protect this product from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Aluminum Starch Octenylsuccinate, Argania Spinosa Kernal Oil, Ascorbic Acid, C12-15 Alkyl Benzoate Carbomer, Dimethicone, Disodium EDTA, Ehtylhexylglycerin, Fragrance, Phenoxyethanol, Polyglyceryl-3 Distearate, Simmondsia Chinesis (Jojoba) Seed Oil, Sorbitan Isostearate, Sorbitol, Stearic Acid, Tocopherol, Triethanolamine, VP/ Eicosene Copolymer, Water.

  • QUESTIONS

    call 1800-914-3880

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    B.TAN SUN SAFE AF FACE  SPF 70
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73978-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73978-004-0188 mL in 1 TUBE; Type 0: Not a Combination Product02/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/11/2021
    Labeler - Marque of Brands Americas, LLC (081170908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marque of Brands Americas, LLC081170908manufacture(73978-004)
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