Skin-so-soft Bug Guard + Spf Gentle Breeze

Skin-so-soft Bug Guard + Spf Gentle Breeze
SPL v4
SPL
SPL Set ID 6255248c-b1e2-47f1-aab0-98fb950b131b
Route
TOPICAL
Published
Effective Date 2013-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Oxybenzone (60 mg) Octisalate (50 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-02-12

Description

Helps prevent sunburn.


Medication Information

Warnings and Precautions

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.

Indications and Usage

Helps prevent sunburn.

Dosage and 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.

Description

Helps prevent sunburn.

Section 44425-7

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

Protect this product from sun.

Section 51727-6

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

Section 51945-4

Section 55105-1

sunscreen

Section 55106-9

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


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 44425-7 (44425-7)

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

Protect this product from sun.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

sunscreen

Section 55106-9 (55106-9)

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


Advanced Ingredient Data


Raw Label Data

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