83447-007

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (15 g)

Inactive Ingredients

Beef Tallow Jojoba Oil Yellow Wax Propolis Wax

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-07-19

Medication Information

Description

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

Zinc Oxide 15%

Warnings

Warnings:

①For external use only. ②Do not use on damaged or broken skin. ③When using this product keep out of eyes. Rinse with water to remove. ④Stop use and ask a doctor if rash occurs. ⑤Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

■ shake well before use

■ apply liberally 15 minutes before sun exposure

■ reapply: 1.after 80 minutes of swimming or sweating. 2. immediately after towel drying. 3.at least every 2 hours

■children after 6 months of age: ask a doctor

■Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularlyuse a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including.

1. limit time in the sun, especially from 10am-2pm

2. wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

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

Inactive Ingredients

Tallow, Jojoba Oil, Beeswax, Propolis

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)

Zinc Oxide 15%

Warnings

Warnings:

①For external use only. ②Do not use on damaged or broken skin. ③When using this product keep out of eyes. Rinse with water to remove. ④Stop use and ask a doctor if rash occurs. ⑤Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

■ shake well before use

■ apply liberally 15 minutes before sun exposure

■ reapply: 1.after 80 minutes of swimming or sweating. 2. immediately after towel drying. 3.at least every 2 hours

■children after 6 months of age: ask a doctor

■Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularlyuse a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including.

1. limit time in the sun, especially from 10am-2pm

2. wear long-sleeve shirts, pants, hats, and sunglasses

Other Information (Other information)

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

Inactive Ingredients

Tallow, Jojoba Oil, Beeswax, Propolis

Advanced Ingredient Data

[{"name": "BEEF TALLOW", "unii": "98HPY76U4W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPOLIS WAX", "unii": "6Y8XYV2NOF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

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": "Zinc Oxide 15%", "Warnings": "Warnings: ①For external use only. ②Do not use on damaged or broken skin. ③When using this product keep out of eyes. Rinse with water to remove. ④Stop use and ask a doctor if rash occurs. ⑤Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "Directions": "Directions ■ shake well before use ■ apply liberally 15 minutes before sun exposure ■ reapply: 1.after 80 minutes of swimming or sweating. 2. immediately after towel drying. 3.at least every 2 hours ■children after 6 months of age: ask a doctor ■Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularlyuse a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including. 1. limit time in the sun, especially from 10am-2pm 2. wear long-sleeve shirts, pants, hats, and sunglasses", "Other information": "Protect the product in this container from excessive heat and direct sun", "Inactive Ingredients": "Tallow, Jojoba Oil, Beeswax, Propolis"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information