Label: SUNSCREEN SPF30 liquid

  • 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 January 18, 2018

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  • ACTIVE INGREDIENT

    Active ingredients--------------purpose

    PEG-100 STEARATE------------ Sunscreen SPF30

    TITANIUM DIOXIDE

    ETHYLHEXYL METHOXYCINNAMATE

    BUTYL METHOXYDIBENZOYLMETHANE

  • WARNINGS

    Warnings:

    Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed: seek medical help or contact a poison control center right away.

  • INDICATIONS & USAGE

    Directions:

    Apply liberally 15 minutes before sun exposure and reapply as need.

  • KEEP OUT OF REACH OF CHILDREN

    Children under 6 months: ask a doctor before use.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    MINERAL OIL, SILICON, 4-HYDROXYBENZOIC ACID, PROPYL ACETATE, MONOGLYCERIDE CITRATE, GETOSTEARYL ALCOHOL, SODIUM DODECYLBENZENESULFONATE, CYCLOMETHICONE, ETHYLENE GLYCOL, WATER, XANTHAN GUM, CARBOMER 940, ALLANTOIN, GLYCERIN, 1,2-BUTANEDIOL, GPL

  • PRINCIPAL DISPLAY PANEL

    image of sunscreen spf 30

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF30 
    sunscreen spf30 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEG-100 STEARATE (UNII: YD01N1999R) (PEG-100 STEARATE - UNII:YD01N1999R) PEG-100 STEARATE2.5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 g
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) (ETHYLHEXYL METHOXYCRYLENE - UNII:S3KFG6Q5X8) ETHYLHEXYL METHOXYCRYLENE1.25 g  in 100 g
    BENZOPHENONE (UNII: 701M4TTV9O) (BENZOPHENONE - UNII:701M4TTV9O) BENZOPHENONE0.5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP) 5 g  in 100 g
    SILICON (UNII: Z4152N8IUI) 1 g  in 100 g
    4-HYDROXYBENZOIC ACID (UNII: JG8Z55Y12H) 0.2 g  in 100 g
    PROPYL ACETATE (UNII: 4AWM8C91G6) 0.1 g  in 100 g
    GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K) 1.5 g  in 100 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 2 g  in 100 g
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) 5 g  in 100 g
    CYCLOMETHICONE (UNII: NMQ347994Z) 2 g  in 100 g
    ETHYLENE GLYCOL (UNII: FC72KVT52F) 0.8 g  in 100 g
    WATER (UNII: 059QF0KO0R) 59.7 g  in 100 g
    XANTHAN GUM (UNII: TTV12P4NEE) 0.25 g  in 100 g
    CARBOMER 940 (UNII: 4Q93RCW27E) 10 g  in 100 g
    ALLANTOIN (UNII: 344S277G0Z) 0.3 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
    1,2-BUTANEDIOL (UNII: RUN0H01QEU) 3 g  in 100 g
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.15 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-216-0110 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
    2NDC:47993-216-0215 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
    3NDC:47993-216-0320 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
    4NDC:47993-216-0430 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
    5NDC:47993-216-0550 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
    6NDC:47993-216-0660 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/20/2015
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD544493972manufacture(47993-216)
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