418d054b-436f-6aa3-e063-6294a90a0f56

SPL v1
SPL
SPL Set ID 418d054b-436f-6aa3-e063-6294a90a0f56
Route
topical
Published
Effective Date 2025-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (4.5 g) avobenzone (1.45 g) octisalate (2.25 g) octocrylene (2.5 g)
Inactive Ingredients
water propanediol dibutyl adipate sodium polyacryloyldimethyl taurate tangerine tocopherol arginine oat polyglyceryl-3 distearate centella asiatica triterpenoids 1,2-hexanediol glyceryl stearate citrate butylene glycol butyloctyl salicylate glycerin tromethamine ethylhexylglycerin xanthan gum carbomer homopolymer, unspecified type rosa damascena flower houttuynia cordata flowering top alcohol caprylyl glycol pomegranate polyglyceryl-3 methylglucose distearate dimethicone polyglyceryl-10 myristate rice bran phenethyl benzoate polymethylsilsesquioxane (4.5 microns)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-10-20

Purpose

sunscreen

Description

Avobenzone 2.9 % Homosalate 9 % Octisalate 4.5 % Octocrylene 5 %


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

Purpose

sunscreen

Directions

■ apply liberally 15 minutes before sun exposure.

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 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

■ children under 6 months of age: Ask a doctor

■ reapply at least every 2 hours

■ use a water-resistant sunscreen if swimming or sweating

• after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

Other Information

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Water/Aqua, Propanediol, Butyloctyl Salicylate, Dibutyl Adipate, Phenethyl Benzoate, Glycerin, Alcohol, Polymethylsilsesquioxane, Polyglyceryl-3 Distearate, 1,2-Hexanediol, Polyglyceryl-3 Methylglucose Distearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Poly C10-30 Alkyl Acrylate, Tromethamine, Ethylhexylglycerin, Glyceryl Stearate Citrate, Sodium Polyacryloyldimethyl Taurate, Dimethicone, Xanthan Gum, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyglyceryl-10 Myristate, Avena Sativa (Oat) Kernel Extract, Centella Asiatica Extract, Citrus Unshiu Fruit Extract, Houttuynia Cordata Extract, Oryza Sativa (Rice) Bran Extract, Punica Granatum Fruit Extract, Rosa Damascena Flower Extract, Schisandra Chinensis Fruit Extract, Tremella Fuciformis (Mushroom) Extract, Tocopherol, Arginine, Carbomer

Description

Avobenzone 2.9 % Homosalate 9 % Octisalate 4.5 % Octocrylene 5 %

Section 51945-4

Stop Use

and ask a doctor if • rash occurs

Do Not Use

• on damaged skin or broken skin

Active Ingredients

Avobenzone 2.9 %

Homosalate 9 %

Octisalate 4.5 %

Octocrylene 5 %

Questions Or Comments?

www.terezandhoner.com, 1-917-587-9381

When Using This Product

• keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children

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


Structured Label Content

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

Purpose

sunscreen

Directions

■ apply liberally 15 minutes before sun exposure.

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 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

■ children under 6 months of age: Ask a doctor

■ reapply at least every 2 hours

■ use a water-resistant sunscreen if swimming or sweating

• after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

Other Information (Other information)

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients (Inactive ingredients)

Water/Aqua, Propanediol, Butyloctyl Salicylate, Dibutyl Adipate, Phenethyl Benzoate, Glycerin, Alcohol, Polymethylsilsesquioxane, Polyglyceryl-3 Distearate, 1,2-Hexanediol, Polyglyceryl-3 Methylglucose Distearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Poly C10-30 Alkyl Acrylate, Tromethamine, Ethylhexylglycerin, Glyceryl Stearate Citrate, Sodium Polyacryloyldimethyl Taurate, Dimethicone, Xanthan Gum, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyglyceryl-10 Myristate, Avena Sativa (Oat) Kernel Extract, Centella Asiatica Extract, Citrus Unshiu Fruit Extract, Houttuynia Cordata Extract, Oryza Sativa (Rice) Bran Extract, Punica Granatum Fruit Extract, Rosa Damascena Flower Extract, Schisandra Chinensis Fruit Extract, Tremella Fuciformis (Mushroom) Extract, Tocopherol, Arginine, Carbomer

Section 51945-4 (51945-4)

Stop Use (Stop use)

and ask a doctor if • rash occurs

Do Not Use (Do not use)

• on damaged skin or broken skin

Active Ingredients

Avobenzone 2.9 %

Homosalate 9 %

Octisalate 4.5 %

Octocrylene 5 %

Questions Or Comments? (Questions or comments?)

www.terezandhoner.com, 1-917-587-9381

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)