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 Type HUMAN OTC DRUG Item Code (Source) NDC:76138-203
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76138-203-09 65 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/01/2012
Labeler - INNOVATION SPECIALTIES (030837314)
Establishment
Name Address ID/FEI Business Operations
CORETEX PRODUCTS INC 061944620 manufacture(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