SPF 30 SUNSCREEN- octinoxate, oxybenzone, octisalate lotion

SPF 30 Sunscreen by

Drug Labeling and Warnings

SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by INNOVATION SPECIALTIES, CORETEX PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Octinoxate 7.5 %

Oxybenzone 4.0 %

Octisalate 1.0 %

PURPOSE

Purpose

Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

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

WARNINGS

Warnings:

For external use only.

DOSAGE & ADMINISTRATION

Dosage and Administration

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF 30 SUNSCREEN 
octinoxate, oxybenzone, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76138-203
Route of Administration	TOPICAL

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)