Broad Spectrum Spf 15 Sunscreen Unflavored Lip Balm

Broad Spectrum Spf 15 Sunscreen Unflavored Lip Balm
SPL v2
SPL
SPL Set ID efe20472-aa84-1cb4-e053-2a95a90abfd8
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

Identifiers & Packaging

Pill Appearance
Color: white
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, 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, 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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