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SPL v1

SPL

SPL Set ID 2ddaa215-7433-c8fa-e063-6394a90a4316

Route

TOPICAL

Published

Effective Date 2024-11-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (25 g)

Inactive Ingredients

Beeswax Shea Butter Propolis Cera Green Tea Leaf Tallow Olive Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-11-01

Description

Tallow, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax), Butyrospermum Parkii (Shea) Butter, Propolis Cera (Propolis), Camellia Sinensis (Green Tea) Leaf Extract

Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse

with water to remove.

Indications and Usage

Indications & Usage: 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.

Dosage and Administration

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

Description

Tallow, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax), Butyrospermum Parkii (Shea) Butter, Propolis Cera (Propolis), Camellia Sinensis (Green Tea) Leaf Extract

Section 50565-1

If product is swallowed,

get medical help or contact a Poison Control Center

right away.

Section 51727-6

Tallow, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax),

Butyrospermum Parkii (Shea) Butter, Propolis Cera (Propolis),

Camellia Sinensis (Green Tea) Leaf Extract

Section 51945-4

Section 55105-1

SUNSCREEN

Structured Label Content

Indications and Usage (34067-9)

Indications & Usage: 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.

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse

with water to remove.

Section 50565-1 (50565-1)

If product is swallowed,

get medical help or contact a Poison Control Center

right away.

Section 51727-6 (51727-6)

Tallow, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax),

Butyrospermum Parkii (Shea) Butter, Propolis Cera (Propolis),

Camellia Sinensis (Green Tea) Leaf Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

SUNSCREEN

Advanced Ingredient Data

[{"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPOLIS CERA", "unii": "6Y8XYV2NOF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GREEN TEA LEAF", "unii": "W2ZU1RY8B0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALLOW", "unii": "98HPY76U4W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OLIVE OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Indications & Usage: 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.", "34068-7": "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", "34071-1": "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.", "50565-1": "If product is swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Tallow, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax), Butyrospermum Parkii (Shea) Butter, Propolis Cera (Propolis), Camellia Sinensis (Green Tea) Leaf Extract", "55105-1": "SUNSCREEN"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:31.612159 · Updated: 2026-03-14T23:07:28.673990