PUBLIX SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [PUBLIX SUPER MARKETS INC]

PUBLIX SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) LOTION [PUBLIX SUPER MARKETS INC]
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NDC 56062-700-16
Set ID 6b552b7c-91c5-4ff4-9d80-3be324dd76bb
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Octinoxate 7.5%
    Oxybenzone 4.5%
  • Purpose

    Sunscreen
  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in water
  • Warnings

    For external use only

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash or irritation develops or lasts.

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

    • shake well
    • apply generously and evenly before sun exposure and as needed
    • children under 6 months of age: ask a doctor
    • reapply frequently and after towel drying, swimming or perspiring
  • Inactive ingredients

    Water, Stearic Acid, Sorbitan Oleate, Sorbitol, Glyceryl Stearate SE, Hydrogenated Soybean Oil, Isopropyl Myristate, Triethanolamine, VP/Eicosene Copolymer, Benzyl Alcohol, Dimethicone, Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice, Imidazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.
  • Principal Display Panel

    Publix
    sunscreen
    LOTION
    15
    SPF
    MOISTURIZING
    VERY WATER RESISTANT
    UVB Protection
    8 FL OZ (237 mL)
    Z00675A0.jpg
  • INGREDIENTS AND APPEARANCE
    PUBLIX SUNSCREEN  SPF 15
    octinoxate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    IMIDUREA (UNII: M629807ATL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-700-16226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/14/2012
    Labeler - Publix Super Markets Inc (006922009)

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