beach bum sunscreen

beach bum sunscreen
SPL v1
SPL
SPL Set ID 29048646-21f4-967b-e063-6394a90abb45
Route
topical
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (2.67 g) octisalate (2.67 mL) octocrylene (0.445 mL) homosalate (0.089 mL)
Inactive Ingredients
glycerin styrene/acrylamide copolymer (mw 500000) edta arachidyl alcohol behenyl alcohol sodium ascorbyl phosphate tocopherol beeswax ethylhexylglycerin isododecane hydrated silica aluminum starch octenylsuccinate phenoxyethanol acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s at 0.5%) aqua glyceryl stearate/peg-100 stearate potassium hydroxide fragrance 13576 polyester-7 neopentyl glycol diheptanoate arachidyl glucoside

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-01

Description

Avobenzone 3.0% Homosalate 8.0% Octisalate 4.5% Octocrylene 6.0% Sunscreen


Medication Information

Warnings

For external use only.

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes of swimming or sweating.

-Immediately after towel drying.

-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 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 10am - 2 pm

Wear long-sleeved shirts, pants, hats and sunglasses.

Directions

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes of swimming or sweating.

-Immediately after towel drying.

-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 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 10am - 2 pm

Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun.

May stain or damage some fabrics, materials or surfaces.

Inactive Ingredients

water, polyester-7, neopentyl glycol diheptanoate, glycerin, styrene/acrylates copolymer, alimunim starch octenylsuccinate, silica, pheoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexyglycerin, acrylates/C10-30 akyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), arachidyl glucoside, glyceryl stearate, PEK-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance.

Description

Avobenzone 3.0% Homosalate 8.0% Octisalate 4.5% Octocrylene 6.0% Sunscreen

Stop Use

Stop use and as a doctor if rash occurs

Back Label

Do Not Use

Do not use on damaged or broken skin.

When Using

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

Front Label

Ask A Doctor

Stop use and ask a doctor if rash occurs.

Keep Out of Reach

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

Active Ingredients

Avobenzone 3.0%

Homosalate 8.0%

Octisalate 4.5%

Octocrylene 6.0%

Sunscreen


Structured Label Content

Warnings (WARNINGS)

For external use only.

Uses (USES)

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions (DIRECTIONS)

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes of swimming or sweating.

-Immediately after towel drying.

-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 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 10am - 2 pm

Wear long-sleeved shirts, pants, hats and sunglasses.

Directions

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes of swimming or sweating.

-Immediately after towel drying.

-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 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 10am - 2 pm

Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information (OTHER INFORMATION)

Protect the product in this container from excessive heat and direct sun.

May stain or damage some fabrics, materials or surfaces.

Inactive Ingredients (INACTIVE INGREDIENTS)

water, polyester-7, neopentyl glycol diheptanoate, glycerin, styrene/acrylates copolymer, alimunim starch octenylsuccinate, silica, pheoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexyglycerin, acrylates/C10-30 akyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), arachidyl glucoside, glyceryl stearate, PEK-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance.

Stop Use (STOP USE)

Stop use and as a doctor if rash occurs

Back Label (BACK LABEL)

Do Not Use (DO NOT USE)

Do not use on damaged or broken skin.

When Using (WHEN USING)

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

Front Label (FRONT LABEL)

Ask A Doctor (ASK A DOCTOR)

Stop use and ask a doctor if rash occurs.

Keep Out of Reach (KEEP OUT OF REACH)

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

Active Ingredients (ACTIVE INGREDIENTS)

Avobenzone 3.0%

Homosalate 8.0%

Octisalate 4.5%

Octocrylene 6.0%

Sunscreen


Advanced Ingredient Data


Raw Label Data

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