FACE AND BODY SUNSCREEN SPRAY SPF 35 (HOMOSALATE, OXYBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]

FACE AND BODY SUNSCREEN SPRAY SPF 35 (HOMOSALATE, OXYBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]
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NDC 68828-092-01
Set ID 9ff5d087-eb0e-4a63-9cf4-33027b2a9d4a
Category HUMAN OTC DRUG LABEL
Packager Jafra Cosmetics International Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Sunscreen active ingredients (SPF 35):

    Homosalate, Octinoxate/Ethylhexyl Methoxycinnamate , Oxybenzone/Benzophenone-3, Octisalate/Ethylhexyl Salicylate, Octocrylene


    Purpose: Sunscreen

    Keep out of reach of children

    Discontinue use if signs of irritation appear.

    Caution: For external use only. Avoid contact with eyes. Seek the advice of a physician prior to use on children under six months of age.

    To use: Apply sunscreen product before exposure. Re-apply frequently to maintain protection, especially after perspiring, swimming, or toweling.


    Other Ingredients:
    Water/Aqua, Acrylates Copolymer, Glycerin, Thermus Thermophillus Ferment, Polysorbate 20, Sorbitan Oleate, DMDM Hydantoin, Cetearyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trethanolamine, Glycyrrhiza Glabra (Licorice) Extract, Moringa Oliefera Extract, Vetivera Zinzanoids (Khus Root) Extract, Withania Somnifera (winter Cherry) Extract, Panthenol, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Trisodium EDTA, Tocopheryl Acetate, Butyrospermum Parkii (Shea Butter) Fruit, Zingiber Officinale (Ginger) Extract, Bisabolol, Butylene Glycol, Pentylene Glycol, Propamidobenzoic Acid.






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  • PRINCIPAL DISPLAY PANEL

    Jafra Sun

    Face and Body Sunscreen Spray SPF 35

    Advanced UV protection

     

    Protector Solar en Spray

    Facial y Corporal FPS 35

    Proteccion Avanzada

    contra rayos





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  • INGREDIENTS AND APPEARANCE
    FACE AND BODY SUNSCREEN SPRAY  SPF 35
    homosalate, oxybenzone, octinoxate, octisalate, octocrylene lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-092
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.79 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MORINGA OLEIFERA BARK (UNII: 1X2218R709)  
    WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SHEANUT OIL (UNII: O88E196QRF)  
    GINGER (UNII: C5529G5JPQ)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-092-01 1 in 1 BOX
    1 125 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 06/05/2012
    Labeler - Jafra Cosmetics International Inc (041676479)
    Registrant - Jafra Cosmetics International Inc (041676479)
    Establishment
    Name Address ID/FEI Business Operations
    Jafra Manufacturing, S.A. de C.V. 814732061 manufacture
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