Yellow Sunblock (shea Butter Sunblock)

Yellow Sunblock (shea Butter Sunblock)
SPL v1
SPL
SPL Set ID 5516b784-23be-2582-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (1.6 g)
Inactive Ingredients
Allantoin Castor Oil Camellia Oil Glycerin .alpha.-tocopherol Shea Butter Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-07-24

Description

Zinc oxide (8%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc oxide (8%)

Uses

Helps prevent sunburn

Warnings

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

- do not apply on other parts of the body

- do not use on damaged or broken skin

- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

- do not apply directly to wound or open cut

Stop use and ask a doctor if

- Rash or irritation on skin develops and lasts

Directions

1. Apply the adequate amount on the palm of the hands and pat lightly with the fingertips.

2. Apply liberally 15 minutes before sun exposure.

3. Reapply at least every 2 hours.

4. Use a water-resistant sunscreen if swimming or sweating.

5. Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- Limit time in the sun, especially from 10 a.m.- 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses.

6. Children under 6 months of age: ask a doctor

Active Ingredients

Zinc oxide (8%)

Inactive Ingredients

Shea butter, Castor oil, Camellia oil, Emulsifying wax, Allantoin, Distilled water, Rose water, Glycerin, Vitamin E oil, Optiphen plus, Aspen Grass Fragrance oil

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Yellow Sunblock (shea Butter Sunblock)


Structured Label Content

Uses

Helps prevent sunburn

Purpose

Sunscreen

Warnings

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

- do not apply on other parts of the body

- do not use on damaged or broken skin

- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

- do not apply directly to wound or open cut

Stop use and ask a doctor if

- Rash or irritation on skin develops and lasts

Directions

1. Apply the adequate amount on the palm of the hands and pat lightly with the fingertips.

2. Apply liberally 15 minutes before sun exposure.

3. Reapply at least every 2 hours.

4. Use a water-resistant sunscreen if swimming or sweating.

5. Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- Limit time in the sun, especially from 10 a.m.- 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses.

6. Children under 6 months of age: ask a doctor

Active Ingredients

Zinc oxide (8%)

Inactive Ingredients

Shea butter, Castor oil, Camellia oil, Emulsifying wax, Allantoin, Distilled water, Rose water, Glycerin, Vitamin E oil, Optiphen plus, Aspen Grass Fragrance oil

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Yellow Sunblock (shea Butter Sunblock) (Yellow Sunblock (Shea Butter Sunblock))


Advanced Ingredient Data


Raw Label Data

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