Sss Bg+ Expedition Spf 30 Pump Spray

Sss Bg+ Expedition Spf 30 Pump Spray
SPL v3
SPL
SPL Set ID 7c5278d0-5bb3-4e00-8966-05560bd4a375
Route
TOPICAL
Published
Effective Date 2013-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) 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

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.

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. 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.

Description

Helps prevent sunburn.

Section 44425-7

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

Protect product from direct sun.

Section 51727-6

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

Section 51945-4

Section 55106-9

ACTIVE SUNSCREEN INGREDIENTS: Octocrylene 10%, 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. 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.

Warnings and Precautions (34071-1)

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.

Section 44425-7 (44425-7)

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

Protect product from direct sun.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

ACTIVE SUNSCREEN INGREDIENTS: Octocrylene 10%, Octinoxate 7.5%, Oxybenzone 6%, Octisalate 5%


Advanced Ingredient Data


Raw Label Data

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