Cream Oil Sunscreen

Cream Oil Sunscreen
SPL v4
SPL
SPL Set ID b2ccdfea-1c27-42af-b9d8-752e9f91ae87
Route
TOPICAL
Published
Effective Date 2020-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (32.6 g) Titanium Dioxide (21 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-04

Description

Zinc Oxide 21.50%...... Sunscreen Titanium Dioxide 1.25%...... Sunscreen

Purpose

Zinc Oxide 21.50%...... Sunscreen Titanium Dioxide 1.25%...... Sunscreen


Medication Information

Purpose

Zinc Oxide 21.50%...... Sunscreen Titanium Dioxide 1.25%...... Sunscreen

Dosage and Administration

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: ask doctor.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10a.m. - 2p.m.

wear long sleeve shirts, pants, hats and sunglasses.

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

Description

Zinc Oxide 21.50%...... Sunscreen Titanium Dioxide 1.25%...... Sunscreen

Uses

Helps protect against sunburn

provides moderate protection against sunburn

Section 43683-2

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: ask doctor.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10a.m. - 2p.m.

wear long sleeve shirts, pants, hats and sunglasses.

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

Section 50565-1

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

Section 51945-4

Section 55105-1

Sunscreen

Warnings

Do not use on damaged or broken skin

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

Stop use and ask doctor if rash occurs

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

Directions

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: ask doctor.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10a.m. - 2p.m.

wear long sleeve shirts, pants, hats and sunglasses.

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

Other Information

Protect the product in this contianer from heat and direct sun.

Active Ingredients Purpose

Zinc Oxide 21.50%...... Sunscreen

Titanium Dioxide 1.25%...... Sunscreen


Structured Label Content

Uses

Helps protect against sunburn

provides moderate protection against sunburn

Dosage and Administration (34068-7)

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: ask doctor.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10a.m. - 2p.m.

wear long sleeve shirts, pants, hats and sunglasses.

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

Section 43683-2 (43683-2)

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: ask doctor.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10a.m. - 2p.m.

wear long sleeve shirts, pants, hats and sunglasses.

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

Section 50565-1 (50565-1)

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Warnings

Do not use on damaged or broken skin

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

Stop use and ask doctor if rash occurs

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

Directions

Apply generously and evenly 15 minutes before sun exposure.

Children under 6 months of age: ask doctor.

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10a.m. - 2p.m.

wear long sleeve shirts, pants, hats and sunglasses.

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

Other Information

Protect the product in this contianer from heat and direct sun.

Active Ingredients Purpose

Zinc Oxide 21.50%...... Sunscreen

Titanium Dioxide 1.25%...... Sunscreen


Advanced Ingredient Data


Raw Label Data

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