Label: ALOE SUN SPF28 PA PLUS PLUS- octinoxate spray

  • 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

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  • ACTIVE INGREDIENT

    Active ingredients: OCTINOXATE 7%, ENSULIZOLE 2%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, C12-15 ALKYL BENZOATE, 4-METHYLBENZYLIDENE CAMPHOR, BUTYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARETH-6 OLIVATE, PEG-7 GLYCERYL COCOATE, ALOE BARBADENSIS LEAF EXTRACT, C12-20 ALKYL GLUCOSIDE, C14-22 ALCOHOLS, DIMETHICONE, MALPIGHIA GLABRA(ACEROLA) FRUIT EXTRACT, GLYCERIN, SODIUM HYDROXIDE, CELLULOSE GUM, CETEARYL OLIVATE, SORBITAN OLIVATE, MICROCRYSTALLINE CELLULOSE, DISODIUM EDTA, ETHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, METHYLPARABEN, PROPYLPARABEN, 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
    ALOE SUN  SPF28 PA PLUS PLUS
    octinoxate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-019
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ENZACAMENE (UNII: 8I3XWY40L9)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-019-01100 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
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