drug facts

drug facts
SPL v2
SPL
SPL Set ID 47ea045a-34a6-43e5-b9fa-fe402ba42ef2
Route
topical
Published
Effective Date 2019-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (2 g) oxybenzone (4.5 g)
Inactive Ingredients
helianthus annuus seed wax synthetic wax (1200 mw) castor oil lanolin coconut oil sorbitan monooleate corn oil .alpha.-tocopherol acetate sucralose

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2019-03-09

Description

Octinoxate 2.0% Oxybenzone 4.5%


Medication Information

Warnings

For external use only

Do not use on damaged or broken skin

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

Stop use and ask a docor if rash or irritation develops and lasts

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Uses

• helps prevent sunburn

Directions

• apply liberally before sun exposure and as needed.

• children under 6 months of age: Ask a doctor

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil, Synthetic Beeswax, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Aroma/Flavor, Sorbitan Oleate, Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT, Sucralose

Description

Octinoxate 2.0% Oxybenzone 4.5%

Principal Display Panel

Active Ingredients

Octinoxate 2.0%

Oxybenzone 4.5%

Questions Or Comments?

1.800.290.0577


Structured Label Content

Warnings

For external use only

Do not use on damaged or broken skin

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

Stop use and ask a docor if rash or irritation develops and lasts

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Uses

• helps prevent sunburn

Directions

• apply liberally before sun exposure and as needed.

• children under 6 months of age: Ask a doctor

Inactive Ingredients (Inactive ingredients)

Helianthus Annuus (Sunflower) Seed Oil, Synthetic Beeswax, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Aroma/Flavor, Sorbitan Oleate, Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT, Sucralose

Principal Display Panel

Active Ingredients

Octinoxate 2.0%

Oxybenzone 4.5%

Questions Or Comments? (Questions or Comments?)

1.800.290.0577


Advanced Ingredient Data


Raw Label Data

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