FDA.reportPublic FDA data

Skin So Soft Bug Guard Plus IR3535

Manufacturer
New Avon LLC
Effective date
2019-01-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:59:43

Label at a glance#

ProductSkin So Soft Bug Guard Plus IR3535 Cool N Fabulous Disappearing Color Insect Repellent Sunscreen
Active ingredientOCTINOXATE, OXYBENZONE, OCTISALATE
Label structure8 sections

Storage and handling

STORAGE: Store in cool, dry place away from heat or flame. Protect this product from sun.

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

Protect this product from sun.

WARNINGS SECTION

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.

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

sunscreen

INACTIVE INGREDIENT SECTION

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, Blue 1, Red 33.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of PDPimage of PDPimage of labelimage of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10096-0071-12021-01-29C16284748780-1ba0f9c33-59d3-a910-e053-dadaa90a0b85SSS BG+ Cool N Fabulous Disappearing Color

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10096-0071-1Skin So Soft Bug Guard Plus IR3535Cool N Fabulous Disappearing Color Insect Repellent Sunscreen118 mL in 1 BOTTLELOTION1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10096-0071SKIN SO SOFT BUG GUARD PLUS IR3535 COOL N FABULOUS DISAPPEARING COLOR INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [NEW AVON LLC]5Legacy NDC, 1 package rows20190618_de0a2f59-a078-480b-b6c6-99be4c572504.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10096-007110096-0071-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8b87a840-ec6e-f8c2-e053-2a95a90a637dde0a2f59-a078-480b-b6c6-99be4c5725042019-01-01WarningsExact identifier
spl id: 8b87a840-ec6e-f8c2-e053-2a95a90a637d
spl set id: de0a2f59-a078-480b-b6c6-99be4c572504

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.