SKIN SO SOFT BUG GUARD PLUS IR3535 EXPEDITION INSECT REPELLENT SUNSCREEN- octocrylene, octinoxate, oxybenzone, octisalate spray

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, Fareva Morton Grove, Inc.. 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. An adult must apply this product to children under age 10. Children under 6 months: Ask a doctor. Do not apply over wounds, freshly shaved or irritated skin.
TO APPLY TO SKIN: Spray liberally and rub product on evenly 15 minutes before sun and insect exposure. TO APPLY TO FACE: Spray palm of hand and rub on, avoiding the eye area. FOR PROTECTION from deer ticks reapply after 10 hours, and for mosquitoes reapply after 8 hours, and for gnats, no-seeums, sand flies and biting midges reapply after 6 hours. For sunscreen protection, reapply immediately after towel drying, after 80 minutes of swimming or sweating, at least every 2 hours. REAPPLY AS NEEDED, NOT TO EXCEED 3 APPLICATIONS PER DAY.

STORAGE AND HANDLING

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

Protect product from direct sun.

WARNINGS

WARNING: For external use only. Causes substantial but temporary eye injury. When using this product keep out of eyes. Do not spray on face, clothing or in eyes. Do not rub eyes with fabric that has contacted product or treated skin. 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: Octocrylene 10%, Octinoxate 7.5%, Oxybenzone 6%, Octisalate 5%

INACTIVE INGREDIENT

OTHER INGREDIENTS: SD Alcohol 40-B, Water, Hexylene glycol, Polyurethane-1, Fragrance, Aloe barbadensis extract, Tocopheryl acetate (Vitamin E)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN SO SOFT BUG GUARD PLUS IR3535  EXPEDITION INSECT REPELLENT SUNSCREEN
octocrylene, octinoxate, oxybenzone, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
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: 10096-0121-1	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/12/2013
2	NDC: 10096-0121-2	59 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package	02/12/2013
3	NDC: 10096-0121-3	236 mL in 1 BOTTLE, SPRAY; 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)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Morton Grove, Inc.		116752326	manufacture(10096-0121)