HIGH PROTECTION SUN AIR SPRAY SPF50 PA - octinoxate octisalate aluminum hydroxide spray 
The Doctor's Cosmetic Inc

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.

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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

CAUTION: Keep away from children.

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.


Label16c



LABEL

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

Revised: 10/2009
Document Id: 5ecf591f-8090-430f-8a18-eed1909b3d26
Set id: 14d80223-b1c2-4f85-b0bd-7b7e4d5b5c5d
Version: 3
Effective Time: 20091001
 
The Doctor's Cosmetic Inc