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

Medication Information

Description

Octinoxate 2.0% Oxybenzone 4.5%

Uses

• helps prevent sunburn

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.

Directions

• apply liberally before sun exposure and as needed.

• children under 6 months of age: Ask a doctor

Active Ingredients

Octinoxate 2.0%

Oxybenzone 4.5%

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

Questions Or Comments?

1.800.290.0577

Principal Display Panel

Structured Label Content

Uses

• helps prevent sunburn

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.

Directions

• apply liberally before sun exposure and as needed.

• children under 6 months of age: Ask a doctor

Active Ingredients

Octinoxate 2.0%

Oxybenzone 4.5%

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

Questions Or Comments? (Questions or Comments?)

1.800.290.0577

Principal Display Panel

Advanced Ingredient Data

[{"name": "HELIANTHUS ANNUUS SEED WAX", "unii": "42DG15CHXV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SYNTHETIC WAX (1200 MW)", "unii": "Q3Z4BCH099", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CASTOR OIL", "unii": "D5340Y2I9G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN MONOOLEATE", "unii": "06XEA2VD56", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CORN OIL", "unii": "8470G57WFM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "4.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "• helps prevent sunburn", "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.", "Directions": "• apply liberally before sun exposure and as needed. • children under 6 months of age: Ask a doctor", "Active Ingredients": "Octinoxate 2.0% Oxybenzone 4.5%", "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", "Questions or Comments?": "1.800.290.0577"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information