2a0c3dd1-4bc0-6664-e063-6294a90af4b3

SPL v3
SPL
SPL Set ID 2a0c3dd1-4bc0-6664-e063-6294a90af4b3
Route
topical
Published
Effective Date 2024-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (7.08 g) octocrylene (16.815 g) octisalate (8.673 g) avobenzone (5.133 g)
Inactive Ingredients
ethyl ferulate aloe barbadensis leaf helianthus annuus (sunflower) seed oil dehydrated alcohol polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) tocopherol acrylates/octylacrylamide copolymer (75000 mw) butyloctyl salicylate carthamus tinctorius (safflower) seed oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-01

Description

Active Ingredient Avobenzone - 2.9% - Homosalate - 4.0% - Octisalate - 4.9% - Octocrylene - 9.5%


Medication Information

Warnings and Precautions

Warnings

For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames.

Protect this product from excessive heat and direct sun

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 a doctor if skin irritation or redness occurs for more than 72 hours.

Active Ingredient

Active Ingredient

Avobenzone - 2.9% - Homosalate - 4.0% - Octisalate - 4.9% - Octocrylene - 9.5%

Indications and Usage

Uses • Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

• For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames.

Protect this product from excessive heat and direct sun

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 a doctor if skin irritation or redness occurs for more than 72 hours.

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day after swimming or sweating. • Children under 6 months: ask a doctor.

Sun Protection Measure: 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.

Dosage and Administration





Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day or after swimming or sweating. • Children under 6 months: ask a doctor.

Sun Protection Measure: 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.

to 2 p.m. • Wear long-sleeved shirts, pants, hats, and sun glasses.

Description

Active Ingredient Avobenzone - 2.9% - Homosalate - 4.0% - Octisalate - 4.9% - Octocrylene - 9.5%

Section 50565-1

Keep out of reach of children:

if product is swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

Inactive Ingredients:



Acrylates/Octylacrylamide Copolymer, Alcohol Denat, Aloe Barbadensis Leaf Extract, Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Seed Oil, Ethyl Ferulate, Helianthus Annuus (Sunflower)

Seed Oil*, Polyester-8, Tocopherol.



* Indicates Certified Organic Ingredient.

Section 51945-4

Section 55105-1


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames.

Protect this product from excessive heat and direct sun

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 a doctor if skin irritation or redness occurs for more than 72 hours.

Active Ingredient (55106-9)

Active Ingredient

Avobenzone - 2.9% - Homosalate - 4.0% - Octisalate - 4.9% - Octocrylene - 9.5%

Indications and Usage (34067-9)

Uses • Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

• For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames.

Protect this product from excessive heat and direct sun

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 a doctor if skin irritation or redness occurs for more than 72 hours.

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day after swimming or sweating. • Children under 6 months: ask a doctor.

Sun Protection Measure: 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.

Dosage and Administration (34068-7)





Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day or after swimming or sweating. • Children under 6 months: ask a doctor.

Sun Protection Measure: 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.

to 2 p.m. • Wear long-sleeved shirts, pants, hats, and sun glasses.

Section 50565-1 (50565-1)

Keep out of reach of children:

if product is swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

Inactive Ingredients:



Acrylates/Octylacrylamide Copolymer, Alcohol Denat, Aloe Barbadensis Leaf Extract, Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Seed Oil, Ethyl Ferulate, Helianthus Annuus (Sunflower)

Seed Oil*, Polyester-8, Tocopherol.



* Indicates Certified Organic Ingredient.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)


Advanced Ingredient Data


Raw Label Data

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