Label: SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

  • 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 June 11, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients        Purpose

    Avobenzone 3%         Sunscreen

    Homosalate 10%        Suncreen

    Octisalate 5%            Suncreen

    Octocrylene 7%         Sunscreen

  • PURPOSE

    Uses

    • 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
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if
    • swimming or sweating
    • reapply at least every 2 hours children under 6 months: Ask a doctor
    • Sun Protection Measures. Spending time in the sun icreases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Specturm SPF 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
  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Actinidia Chinensis (Kiwi) Fruit Water, Alcohol, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol,
    Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Chlorphenesin, Cocos Nucifera Fruit Extract, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Maltodextrin, Moringa Oleifera Leaf Extract, PEG-100 Stearate, Phenethyl Alcohol, Polygonum Aviculare Extract, Royal Jelly, Sodium Ascorbyl Phosphate, Sophora Flavescens Root Extract, Styrene/Acrylate Copolymer, Tetrapeptide-45, Water/Aqua

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    Royal Jelly

    Solar Protection Fluid

    Broad Spectrum SPF 50

    50 ml   1.7 FL OZ (US)

    Carton

  • INGREDIENTS AND APPEARANCE
    SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-282
    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) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    KIWI FRUIT OIL (UNII: 66086CWP3Q)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    ARGININE (UNII: 94ZLA3W45F)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    COCONUT (UNII: 3RT3536DHY)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    ROYAL JELLY (UNII: L497I37F0C)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-282-021 in 1 CARTON08/10/2015
    1NDC:68828-282-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/10/2015
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V814732061manufacture(68828-282)
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