Label: BLEVE BVIBRANT- octyl methoxycinnamate 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 March 20, 2012

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  • ACTIVE INGREDIENT

    OCTYL METHOXYCINNAMATE 2%

    AVOBENZONE 0.5%

  • PURPOSE

    SKIN PROTECTANT

    SKIN PROTECTANT

  • USES

    HELPS PREVENT SUNBURN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

  • 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 HELP PREVENT SUNBURN, NOT SKIN CANCER OR EARLY SKIN AGING.

  • WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

  • STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

  • KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    APPLY LIBERALLY 15 MINUTES BEFORE EXPOSURE TO SUN. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY TWO HOURS. FOR CHILDREN UNDER 6 MONTHS, ASK A DOCTOR.

  • INACTIVE INGREDIENTS

    WATER (AQUA), CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES, GLYCINE SOJA (SOYBEAN) OIL, C12-15 ALKYL BENZOATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, GLYCERYL STEARATE, CETYL ALCOHOL, STEARYL ALCOHOL, DIMETHICONE,VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, ISOMALT, LECITHIN, SODIUM BENZOATE, PALMITOYL TRIPEPTIDE-38, GLYCERIN, HYDROXYPROPYL CYCLODEXTRIN, INULIN, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, FRAGRANCE (PARFUM), PHENOXYETHANOL, TROPOLONE.

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    BLEVE  BVIBRANT
    octyl methoxycinnamate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-353
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    VITIS VINIFERA FLOWERING TOP (UNII: 6TG3V35HTV)  
    ISOMALT (UNII: S870P55O2W)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYLBETADEX (0.58-0.68 MS) (UNII: 1I96OHX6EK)  
    INULIN (UNII: JOS53KRJ01)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-353-04118 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/19/2012
    Labeler - TOPCO ASSOCIATES LLC (006935977)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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