83447-009

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (15 g)

Inactive Ingredients

Beef Tallow Olive Oil Yellow Wax Shea Butter Propolis Wax Green Tea Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-08-09

Medication Information

Description

Non-Nano Zinc Oxide 15%

Uses

■helps prevent sunburn

■if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early

skin aging caused by the sun

Section 50565-1

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

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

Section 55105-1

sunscreen

Section 55106-9

Non-Nano Zinc Oxide 15%

Warnings

① For external use only.

② When using this product keep out of eyes. Rinse with water to remove.

③ Stop use and ask a doctor if rash occurs.

Directions

Directions

■ shake well before use apply liberally 15 minutes before sun exposure

■ reapply: ●after 80 minutes of swimming or sweating ●immediately after towel drying ●at least every 2 hours

■ children after 6 months of age: ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Tallow, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax), Butyrospermum Parkii (Shea) Butter, Propolis Cera (Propolis)，

Camellia Sinensis (Green Tea) Leaf Extract

Structured Label Content

Uses

■helps prevent sunburn

■if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early

skin aging caused by the sun

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

sunscreen

Section 55106-9 (55106-9)

Non-Nano Zinc Oxide 15%

Warnings

① For external use only.

② When using this product keep out of eyes. Rinse with water to remove.

③ Stop use and ask a doctor if rash occurs.

Directions

Directions

■ shake well before use apply liberally 15 minutes before sun exposure

■ reapply: ●after 80 minutes of swimming or sweating ●immediately after towel drying ●at least every 2 hours

■ children after 6 months of age: ask a doctor

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Tallow, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax), Butyrospermum Parkii (Shea) Butter, Propolis Cera (Propolis)，

Camellia Sinensis (Green Tea) Leaf Extract

Advanced Ingredient Data

[{"name": "BEEF TALLOW", "unii": "98HPY76U4W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLIVE OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PROPOLIS WAX", "unii": "6Y8XYV2NOF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GREEN TEA LEAF", "unii": "W2ZU1RY8B0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "■helps prevent sunburn ■if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "50570-1": "Do not use on damaged or broken skin.", "55105-1": "sunscreen", "55106-9": "Non-Nano Zinc Oxide 15%", "Warnings": "① For external use only. ② When using this product keep out of eyes. Rinse with water to remove. ③ Stop use and ask a doctor if rash occurs.", "Directions": "Directions ■ shake well before use apply liberally 15 minutes before sun exposure ■ reapply: ●after 80 minutes of swimming or sweating ●immediately after towel drying ●at least every 2 hours ■ children after 6 months of age: ask a doctor", "Other information": "Protect the product in this container from excessive heat and direct sun.", "Inactive Ingredients": "Tallow, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax), Butyrospermum Parkii (Shea) Butter, Propolis Cera (Propolis)， Camellia Sinensis (Green Tea) Leaf Extract"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information