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BB ANTI-FATIGUE ABSOLUTE SPF 25 (ORLANE S.A.)

Available Formats

Dosage Form Package Information Links
CREAM 1 TUBE in 1 CARTON (65371-025-02) > 30 mL in 1 TUBE Label Information

Complete BB ANTI-FATIGUE ABSOLUTE SPF 25 Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Homosalate 9% Sunscreen
    Octisalate 4.5% Sunscreen
    Oxybenzone 3% Sunscreen

  • Use

    helps prevent sunburn


  • Warnings

    For external use only

    Skin Cancer / Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

    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
    • children under 6 months of age : ask a doctor.
    • reapply at least every 2 hours.
    • use a water resistant sunscreen if swimming or sweating.

  • Other information

    protect the product in this container from excessive heat and direct sun.


  • Inactive ingredients

    water, glycerin, dimethicone, polymethyl methacrylate, propanediol, butylene glycol, glyceryl stearate, cetearyl alcohol, peg-100 stearate, benzimidazole diamond amidoethyl urea carbamoyl propyl polymethylsilsesquioxane, cetyl alcohol, peg-75 stearate, propylene glycol, phenoxyethanol, polygyceryl-3 diisostearate, ceteth-20, chlorphenesin, steareth-20, evodia rutaecarpa fruit extract, xanthan gum, fragrance, o-cymen-5-ol, tetrasodium edta, lactic acid, sodium hyaluronate, tocopherol, panax ginseng root extract, pentylene glycol, hydrolyzed rice protein, chlorhexidine digluconate, ginkgo biloba leaf extract, hydrolyzed soy protein, potassium sorbate, (may contain: titanium dioxide, iron oxides).


  • PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

    ORLANE
    PARIS

    BB CREAM SPF 25
    ANTI-FATIGUE ABSOLUTE
    SUNSCREEN

    30 ml e
    NET WT. 1 OZ.

    PRINCIPAL DISPLAY PANEL - 30 ml  Tube Carton

  • INGREDIENTS AND APPEARANCE
    BB ANTI-FATIGUE ABSOLUTE SPF 25 
    homosalate, octisalate, and oxybenzone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65371-025
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Propanediol (UNII: 5965N8W85T)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polyglycerin-3 (UNII: 4A0NCJ6RD6)  
    Ceteth-20 (UNII: I835H2IHHX)  
    Tetradium Ruticarpum Fruit (UNII: Q413WWJ3X9)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    O-Cymen-5-OL (UNII: H41B6Q1I9L)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Asian Ginseng (UNII: CUQ3A77YXI)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65371-025-02 1 in 1 CARTON
    1 30 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part352 04/01/2013
    Labeler - ORLANE S.A. (131360992)
    Establishment
    Name Address ID/FEI Business Operations
    ORLANE, ORLEANS 578687469 MANUFACTURE(65371-025)