Label: HIGH PROTECTION SUN AIR SPRAY SPF50 PA- octinoxate octisalate aluminum hydroxide 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 October 1, 2009

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

View All Sections
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    Water, Cyclopentasiloxane, Ethylhexyl Methosycinnamate, Alcohol, Zinc Oxide, Ethylhexyl Salicylate, Isodecyl Neopentanoate, Butylene Glycol, Titanium Dioxide, Peg-10 Dimethicone, Methyl Methacrylate Crosspolymer, Methicone, Aluminum Stearate, Aluminum Hydroxide, Sodium Chloride, Fragrance, Calcium Aluminum Borosilicate, Imidazolidinyl Urea, Polyglyceryl-6 Polyricinoleate, Sodium Hyaluronate, Rosemarinus Officinalis (Rosemary) Leaf Extract, Opuntia Ficus - Indica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Methylparaben, Propylparaben, Butylparaben

  • KEEP OUT OF REACH OF CHILDREN

    CAUTION: Keep away from children.

  • WHEN USING

    DIRECTION OF USE:

    Apply 15-30 minutes before sun exposure.  Do not apply in windy conditions.  Hold can 4-6 inches away from body and apply liberally, spraying slowly and evenly until product is visible on skin.  Spray into hand and apply to the face.  Use in well ventilated areas.  Reapply after swimming, excessive perspiration, towel drying or extended sun exposure.

  • PRINCIPAL DISPLAY PANEL


    Label16c



    LABEL

  • INGREDIENTS AND APPEARANCE
    HIGH PROTECTION SUN AIR SPRAY SPF50 PA 
    octinoxate octisalate aluminum hydroxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43948-6001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE9.75 mL  in 130 mL
    Inactive Ingredients
    Ingredient NameStrength
    OCTISALATE (UNII: 4X49Y0596W)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43948-6001-1130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/01/2009
    Labeler - The Doctor's Cosmetic Inc (687479378)
    Registrant - The Doctor's Cosmetic Inc (687479378)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Doctor's Cosmetic Inc687479378manufacture
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!