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

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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Skin-So-Soft Bug Guard + SPF Gentle Breeze

Helps prevent sunburn.

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

Protect this product from sun.

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

sunscreen

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

image of PDPimage of label

SKIN SO SOFT BUG GUARD PLUS IR3535  GENTLE BREEZE INSECT REPELLENT SUNSCREEN
octinoxate, oxybenzone, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-8026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10096-8026-1118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/12/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/12/2013
Labeler - New Avon LLC (080143520)

Revised: 1/2019
Document Id: 84265799-123c-abc0-e053-2991aa0a8bc4
Set id: 6255248c-b1e2-47f1-aab0-98fb950b131b
Version: 4
Effective Time: 20190101
 
New Avon LLC