SPF 30 SUNSCREEN- octinoxate, oxybenzone, 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 DRUGItem Code (Source)NDC:76138-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76138-203-0965 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/201205/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/01/201205/13/2022
Labeler - INNOVATION SPECIALTIES (030837314)
Establishment
NameAddressID/FEIBusiness Operations
CORETEX PRODUCTS INC061944620manufacture(76138-203)

Revised: 5/2022
 
INNOVATION SPECIALTIES