SPL v3
SPL
SPL Set ID 38d8c1c9-86b5-1edd-e063-6394a90aeb47
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (9 g) Octisalate (4.5 g) Homosalate (13.6 g) Avobenzone (2.7 g)
Inactive Ingredients
Tocopherol Hyaluronic Acid Butyloctyl Salicylate Propanediol C20-22 Alcohols Caprylyl Methicone Pentylene Glycol Glyceryl Stearate Polyacrylate Crosspolymer-6 Butylene Glycol Ethylhexylglycerin Sodium Hyaluronate Panthenol Glycerin C20-22 Alkyl Phosphate Cetyl Alcohol 1,2-hexanediol Tromethamine Ammonium Acryloyldimethyltaurate/vp Copolymer

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

For external use only 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 • rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

For external use only 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 • rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Artwork

Warnings

For external use only

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 • rash occurs

Keep out of reach of children.

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

Directions

For sunscreen use

• Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours

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

Inactive Ingredients

WATER, BUTYLOCTYL SALICYLATE, PROPANEDIOL, POLYMETHYLSILSESQUIOXANE, C20-22 ALKYL PHOSPHATE, C20-22 ALCOHOLS, PANTHENOL, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, PENTYLENE GLYCOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CETYL ALCOHOL, VP/EICOSENE COPOLYMER, GLYCERYL STEARATE, TROMETHAMINE

POLYACRYLATE CROSSPOLYMER-6, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, SILICA, BUTYLENE GLYCOL, CENTELLA ASIATICA EXTRACT, ETHYLHEXYLGLYCERIN, HYDROLYZED SODIUM HYALURONATE, SODIUM HYALURONATE, TOCOPHEROL, GLYCERIN, PORTULACA OLERACEA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, HYALURONIC ACID, ORYZA SATIVA (RICE) EXTRACT, AVENA SATIVA (OAT) MEAL EXTRACT, GLYCINE MAX (SOYBEAN) SEED EXTRACT

Keep Out of Reach of Children

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


Structured Label Content

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

Artwork (artwork)

Warnings

For external use only

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 • rash occurs

Keep out of reach of children.

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

Directions

For sunscreen use

• Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours

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

Inactive Ingredients (Inactive ingredients)

WATER, BUTYLOCTYL SALICYLATE, PROPANEDIOL, POLYMETHYLSILSESQUIOXANE, C20-22 ALKYL PHOSPHATE, C20-22 ALCOHOLS, PANTHENOL, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, PENTYLENE GLYCOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CETYL ALCOHOL, VP/EICOSENE COPOLYMER, GLYCERYL STEARATE, TROMETHAMINE

POLYACRYLATE CROSSPOLYMER-6, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, SILICA, BUTYLENE GLYCOL, CENTELLA ASIATICA EXTRACT, ETHYLHEXYLGLYCERIN, HYDROLYZED SODIUM HYALURONATE, SODIUM HYALURONATE, TOCOPHEROL, GLYCERIN, PORTULACA OLERACEA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, HYALURONIC ACID, ORYZA SATIVA (RICE) EXTRACT, AVENA SATIVA (OAT) MEAL EXTRACT, GLYCINE MAX (SOYBEAN) SEED EXTRACT

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

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