Spf 15 (avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 8.0%)

Spf 15 (avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 8.0%)
SPL v2
SPL
SPL Set ID 393b59aa-6d5a-4757-9f6d-59f7533aee86
Route
TOPICAL
Published
Effective Date 2025-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (15 g) Ethylhexyl Salicylate (5 g) Octocrylene (8 g)
Inactive Ingredients
Ascorbyl Palmitate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (40000 Mw) Alcohol Aloe Barbadensis Leaf Juice Caprylic/capric Triglyceride Citric Acid Fragrance 13576 Glycerin Orange Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-25

Description

· helps prevent sunburn


Medication Information

Description

· helps prevent sunburn

Uses

· helps prevent sunburn

Section 51945-4

Warnings



Flammable:Do not use near heat, flame or while smoking.

Do not useon damaged or broken skin.

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

remove. · Do not puncture or incinerate. Contents under pressure. Do

not store at temperatures above 1200F.

Stop use and ask doctor ifrash occurs.

Directions

Shake well before usng · spray liberally and spread evenly by hand 15 minutes before sun exposure · reapply: · after 80

minutes of swimming or sweating · immediately after towel drying · at least every 2 hours · hold container 4 tob 6 inches from the skin to

apply · do not spray directly into face. Spray on hands then apply to face · do not apply in windy conditions · use in a well-ventilated area.

· 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 of 15 or higher and other sun protection measures including · limit time in the sun, especially

from 10 a.m. - 2 p.m. · wear a long-sleeved shirts, pants, hats, and sunglasses. · children under 6 months: Ask a doctor.

Inactive Ingredients

6-O-palmitoylascorbic acid,

Acrylates/Octylacrylamide Copolymer, Alcohol Barbadensis Leaf

Extract, Caprylic/Capric Triglyceride, Citric Acid, Ethanol, Fragrance,

Glycerin, Orange Oil, Tocopherol Acetate

Other Information ·

protect this product from excessive heat and direct sun · may stain fabrics.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Active Ingredients                                      Purpose


Structured Label Content

Uses

· helps prevent sunburn

Section 51945-4 (51945-4)

Warnings



Flammable:Do not use near heat, flame or while smoking.

Do not useon damaged or broken skin.

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

remove. · Do not puncture or incinerate. Contents under pressure. Do

not store at temperatures above 1200F.

Stop use and ask doctor ifrash occurs.

Directions

Shake well before usng · spray liberally and spread evenly by hand 15 minutes before sun exposure · reapply: · after 80

minutes of swimming or sweating · immediately after towel drying · at least every 2 hours · hold container 4 tob 6 inches from the skin to

apply · do not spray directly into face. Spray on hands then apply to face · do not apply in windy conditions · use in a well-ventilated area.

· 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 of 15 or higher and other sun protection measures including · limit time in the sun, especially

from 10 a.m. - 2 p.m. · wear a long-sleeved shirts, pants, hats, and sunglasses. · children under 6 months: Ask a doctor.

Inactive Ingredients (Inactive ingredients)

6-O-palmitoylascorbic acid,

Acrylates/Octylacrylamide Copolymer, Alcohol Barbadensis Leaf

Extract, Caprylic/Capric Triglyceride, Citric Acid, Ethanol, Fragrance,

Glycerin, Orange Oil, Tocopherol Acetate

Other Information · (Other information ·)

protect this product from excessive heat and direct sun · may stain fabrics.

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

If swallowed, get medical help or contact a Poison Control Center immediately.

Active Ingredients                                      Purpose


Advanced Ingredient Data


Raw Label Data

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