SKIN SO SOFT BUG GUARD PLUS IR3535 GENTLE BREEZE INSECT REPELLENT SUNSCREEN- octinoxate, oxybenzone, octisalate lotion

Skin So Soft Bug Guard Plus IR3535 by

Drug Labeling and Warnings

Skin So Soft Bug Guard Plus IR3535 by is a Otc medication manufactured, distributed, or labeled by New Avon LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Helps prevent sunburn.

DOSAGE & ADMINISTRATION

DIRECTIONS FOR USE: It is a violation of Federal law to use this product in a manner inconsistent with its labeling. Apply liberally 15 minutes before sun and insect exposure. An adult must apply this product to children under 10. Children under 6 months: Ask a doctor. For insect protection, reapply about every 2 hours or sooner if effectiveness diminishes. For sunscreen protection, reapply immediately after towel drying, after 80 minutes of swimming or sweating, at least every 2 hours. Do not exceed 9 applications per day.

STORAGE AND HANDLING

STORAGE: Store in cool, dry place away from heat or flame

Protect this product from sun.

WARNINGS

Caution. For external use only. Causes moderate eye irritation. When using this product keep out of eyes. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. Keep out of reach of children.Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

ACTIVE INGREDIENT

ACTIVE SUNSCREEN INGREDIENTS: Octinoxate 7.5%, Oxybenzone 6%, Octisalate 5%

PURPOSE

sunscreen

INACTIVE INGREDIENT

OTHER INGREDIENTS: Water, Butylene Glycol, Glycerin, PVP/Eicosene Copolymer, Aloe Barbadensis Gel, Isostearic Acid, Propylene Glycol Myristyl Ether Acetate, Stearic Acid, Benzyl Alcohol, Cetyl Alcohol, DEA-Oleth-3 Phosphate, Diglycol/CHDM/Isophthalates/SIP Copolymer, Dimethicone, Glyceryl Stearate, Magnesium Aluminum Silicate, Tocopheryl Acetate, Barium Sulfate, Fragrance, Imidazolidinyl Urea, Xanthan Gum, Disodium EDTA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN SO SOFT BUG GUARD PLUS IR3535  GENTLE BREEZE INSECT REPELLENT SUNSCREEN
octinoxate, oxybenzone, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-8026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-8026-1	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/12/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/12/2013

Labeler - New Avon LLC (080143520)