Label: BROCCOLI SUN SPF42 PA PLUS PLUS PLUS- octinoxate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 8, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients: OCTINOXATE 5%, OCTISALATE 5%, ZINC OXIDE 3.8%, TITANIUM DIOXIDE 2.87%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DIETHYLHEXYL CARBONATE, ISOAMYL p-METHOXYCINNAMATE, CETYL CAPRYLATE, DIMETHICONE, CYCLOHEXASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, STEARALKONIUM HECTORITE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE,
    PEG-30 DIPOLYHYDROXYSTEARATE, SODIUM CHLORIDE, PEG-10 DIMETHICONE, OZOKERITE, PROPYLENE CARBONATE, POLYGLYCERYL-4 ISOSTEARATE, SORBITAN SESQUIOLEATE, ALCOHOL DENAT., HEXYL LAURATE, SORBITAN OLIVATE, TRIMETHOXYCAPRYLYLSILANE, DIMETHICONE, ALOE BARBADENSIS LEAF EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, BUTYLENE GLYCOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, PROPYLENE GLYCOL, DISODIUM EDTA, METHYLPARABEN, BUTYLPARABEN, FRAGRANCE

  • PURPOSE

    Purpose: Protects skin from UV rays.

  • WARNINGS

    Warnings:
    For external use only. Avoid contact with eyes.
    Discontinue use if signs of irritation appear.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indication and usage: Use at the end of your daily skincare regimen. Apply liberally onto face and body before sun exposure avoiding the eye area.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    For best results, apply at least 15 to 20 minutes before sun exposure.
    Reapply frequently while out in the sun.

  • PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    BROCCOLI SUN  SPF42 PA PLUS PLUS PLUS
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-018
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 mL  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 mL  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.9 mL  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.44 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
    CETYL OCTANOATE (UNII: 418Q5V6PLJ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BROCCOLI (UNII: UOI4FT57BZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    PURSLANE (UNII: M6S840WXG5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-018-0150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2011
    Labeler - SKINFOOD CO., LTD. (690324173)
    Registrant - SKINFOOD CO., LTD. (690324173)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINFOOD CO., LTD.690324173manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!