Label: 3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20- avobenzone, homosalate, octisalate, octocrylene jelly

  • NDC Code(s): 68828-283-01
  • Packager: Jafra cosmetics International
  • 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 March 27, 2019

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Avobenzone 3% Sunscreen

    Homosalate 10% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 10% 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 product is swallowed, get medical help or contact a poison Control Center right away

  • 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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if

    rash occurs or irritation develops and lasts.

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • reapply at leastevery 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 with a Broad Spectrum SPF value of 15 or higher and other sun
    protection measures including:

    • limit your time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Inactive ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl
    Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Blsabolol, Butylene Glycol, Butyloctyl Salicylate, Butylphenyl Methylpropional (LIIIIal), Butyrospanmum Parkll (Shea) Butter, C13-16 Isoparaffin, Caffeine, Capryloyl Glycerin/Sabacic Acid Copolymer, Cetyl Alcohol, citral, citronellol, Coumarin, Dimethicone, Dipropylene Glycol, Disodium EDTA, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Heptyl Undecylenate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Limonene, Linalool, Maltodextrin, PEG-100 Stearate, Phenethyl Alcohol, Phenoxyethanol, Polyester-8, Polyquatemlum-51, Quercus Petraea Fruit Extract, Royal Jelly Powder, Royal Jelly, Salix Alba (Willow) Bark Extract, Silica, Sodium Acrylates Crosspolymer-2, Sodium Hyaluronate, Sodium PCA, Styrene/Acrylates Copolymer, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Tocopherol, Trehalose, Triacetin, Urea, Water/Aqua, Xanthan Gum, Yeast Extract

  • PRINCIPAL DISPLAY PANEL

    Jafra Royal Men

    Royal Jelly

    3-in-1 Face Moisturizer Broad Spectrum SPF 20

    75 ml 2.5 Fl Oz

    carton

  • INGREDIENTS AND APPEARANCE
    3-IN-1 FACE MOISTURIZER BROAD SPECTRUM SPF 20 
    avobenzone, homosalate, octisalate, octocrylene jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-283
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 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
    Inactive Ingredients
    Ingredient NameStrength
    ROYAL JELLY (UNII: L497I37F0C)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    UREA (UNII: 8W8T17847W)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIACETIN (UNII: XHX3C3X673)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALLANTOIN, (+)- (UNII: XDK458E1J9)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    CAFFEINE (UNII: 3G6A5W338E)  
    CITRAL (UNII: T7EU0O9VPP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCOA (UNII: D9108TZ9KG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COUMARIN (UNII: A4VZ22K1WT)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    ARGININE (UNII: 94ZLA3W45F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TREHALOSE (UNII: B8WCK70T7I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-283-0175 mL in 1 CARTON; Type 0: Not a Combination Product03/27/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/27/2019
    Labeler - Jafra cosmetics International (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-283)