Broad Spectrum Spf 15 Sunscreen Vanilla Mint Lip Balm

Broad Spectrum Spf 15 Sunscreen Vanilla Mint Lip Balm
SPL v2
SPL
SPL Set ID efe25551-777c-5336-e053-2a95a90a5c23
Route
TOPICAL
Published
Effective Date 2022-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.13 g) Octinoxate (0.28 g) Octocrylene (0.06 g) Octisalate (0.21 g)
Inactive Ingredients
White Petrolatum Paraffin Soybean Oil Ceresin Coconut Oil Mineral Oil Tocopherol Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-13

Description

Active Ingredients: Avobenzone 3.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Description

Active Ingredients: Avobenzone 3.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Section 50565-1

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

Section 50567-7

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

Section 50569-3

Stop use and ask doctor if rash occurs

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive Ingredients: Petrolatum, Mineral Oil, Paraffin Wax, Ozokerite Wax, Coconut Oil, Flavor, Peppermint Oil, Tocopherol, Soybean Oil.

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients:

Avobenzone 3.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Section 60562-6

Directions: Apply liberally 15 mintues before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 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, 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 sleeved shirts, pants, hats, and sunglasses.


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Stop use and ask doctor if rash occurs

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive Ingredients: Petrolatum, Mineral Oil, Paraffin Wax, Ozokerite Wax, Coconut Oil, Flavor, Peppermint Oil, Tocopherol, Soybean Oil.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Avobenzone 3.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Section 60562-6 (60562-6)

Directions: Apply liberally 15 mintues before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 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, 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 sleeved shirts, pants, hats, and sunglasses.


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