SPF 30 SUNSCREEN - octinoxate, oxybenzone and octisalate lotion 
INNOVATION SPECIALTIES

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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Drug Facts

Active Ingredients

Octinoxate 7.5 %

Oxybenzone 4.0 %

Octisalate 1.0 %

Purpose

Sunscreen

Keep out of reach of children, If swallowed get medical help or contact  a Poison Control Center.

Directions

Apply liberally 15-20 minutes before sun exposure. Reapply as needed or after towel drying, Swimming or perspiring.

Warnings:

For external use only.

Dosage and Administration

Apply liberally 15-20 minutes before sun exposure. Reapply as needed or after towel drying, Swimming or perspiring.

Inactive Ingredients

Water, Mineral Oil, Stearic Acid, Cetearyl Alcohol (and) Polysorbate 60, Cetyl Alcohol, Glyceryl Stearate SE, Sodium Lauryl Sulfate, Triethanolamine, Diazolidinyl Urea, Dimethicone, Carbomer, Methyl Paraben, Proplyparaben.

Product Label

SPF 30 SUNSCREEN 
octinoxate, oxybenzone, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76138-203
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE4 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
STEARIC ACID 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
CETYL ALCOHOL 
GLYCERYL STEARATE SE 
SODIUM LAURYL SULFATE 
TROLAMINE 
DIAZOLIDINYL UREA 
DIMETHICONE 
CARBOMER COPOLYMER TYPE A 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76138-203-0965 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2012
Labeler - INNOVATION SPECIALTIES (030837314)
Establishment
NameAddressID/FEIBusiness Operations
CORETEX PRODUCTS INC061944620manufacture(76138-203)

Revised: 11/2012
Document Id: 7a2b3590-021b-4796-9a8d-ad22703146cb
Set id: 6e180f11-42dd-49f9-a653-92d85bb07b75
Version: 2
Effective Time: 20121113
 
INNOVATION SPECIALTIES