Label: SUN BLOCK SPRARY- sun block sprary spf15 spray

  • 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 October 22, 2019

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  • ACTIVE INGREDIENT

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

    HOMOSALATE 3%------------Sunscreen SPF15

    OCTINOXATE 6%

  • PURPOSE

    Uses:

    help prevent sunburn

  • 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. Kepp 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 15mintues before sun exposure and reapply as needed.

  • KEEP OUT OF REACH OF CHILDREN

    Children under 6 months: ask a doctor before use.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    PROPYLENE GLYCOL, CYCLOMETHICONE, PEG-40 CASTOR OIL, SODIUM HYDROXIDE, CARBOMER 1342, METHYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE, DISODIUM EDTA-COPPER, WATER

  • PRINCIPAL DISPLAY PANEL

    image of sun block lotion

  • INGREDIENTS AND APPEARANCE
    SUN BLOCK SPRARY 
    sun block sprary spf15 spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z) 6 g  in 100 g
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 1 g  in 100 g
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U) 0.03 g  in 100 g
    CARBOMER 1342 (UNII: 809Y72KV36) 0.2 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 8 g  in 100 g
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.5 g  in 100 g
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) 0.07 g  in 100 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.15 g  in 100 g
    WATER (UNII: 059QF0KO0R) 75.05 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-215-0110 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    2NDC:47993-215-0215 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    3NDC:47993-215-0330 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    4NDC:47993-215-0560 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    5NDC:47993-215-0680 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    6NDC:47993-215-08100 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    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(47993-215)
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