Label: SUNSCREEN- oxybenzone,octinoxate,octisalate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 18, 2018

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  • Active Ingredients

    Octinoxate 7.5%,Octisalate 2.0%,Oxybenzone 4.0%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • WARNINGS:

    Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This products has been shown only to prevent sunburn, not skin cancer or early skin aging. 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. Stop use and ask a doctor if rash occurs

  • Keep out of reach of children.

    If product swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

  • Inactive ingredients

    Water, Stearic acid , Hexadecan-1-ol, Lanolin , Mineral oil, Glyceryl Stearate, POLYSORBATE80, Sorbitan Stearate,Glycerin,DMDM Hydantoin,Frangrance

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    oxybenzone,octinoxate,octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71011-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HEXADECANAL (UNII: WQD27655QE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71011-004-01100 in 1 BOX07/18/2018
    130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/18/2018
    Labeler - NingBo Huize Commodity Co.,Ltd. (544434795)
    Registrant - NingBo Huize Commodity Co.,Ltd. (544434795)
    Establishment
    NameAddressID/FEIBusiness Operations
    NingBo Huize Commodity Co.,Ltd.544434795manufacture(71011-004)
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