35272744-8253-046c-e063-6394a90aabc2

SPL v2
SPL
SPL Set ID 35272744-8253-046c-e063-6394a90aabc2
Route
topical
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (7 g) octocrylene (9 g) octisalate (4.5 g) avobenzone (2.85 g)
Inactive Ingredients
cetyl alcohol ethylhexyl methoxycrylene water sorbitan olivate pyrus malus (apple) fruit butyloctyl salicylate 1,2-hexanediol butylene glycol propanediol tromethamine centella asiatica flowering top hyaluronic acid hydroxyethyl urea panthenol cetearyl olivate xanthan gum ethylhexylglycerin centella asiatica triterpenoids tocopherol pentylene glycol behenyl acrylate polymer silica

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-07-01

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.


Medication Information

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.

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 generously and evenly 15 minutes before sun exposure

■ Children under 6 months of age: Ask a doctor

■ Reapply at least every 2 hours

■ Use a water resistant sunscreen if swimming or sweating

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

Inactive Ingredients

Water, Propanediol, Butylene Glycol, Butyloctyl Salicylate, Ethylhexyl Methoxycinnamate, Silica, 1,2-Hexanediol, Pentylene Glycol, Hydroxyethyl Urea, Cetearyl Olivate, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, Cetyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Xanthan Gum, Ethylhexylglycerin, Centella Asiatica Extract, Panthenol, Tocopherol, Centella Asiatica Flower/Leaf/Stem Extract, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Pyrus Malus (Apple) Fruit Extract

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.

Section 51945-4

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

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

Purpose

Sunscreen

Directions

■ Apply generously and evenly 15 minutes before sun exposure

■ Children under 6 months of age: Ask a doctor

■ Reapply at least every 2 hours

■ Use a water resistant sunscreen if swimming or sweating

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

Inactive Ingredients (Inactive ingredients)

Water, Propanediol, Butylene Glycol, Butyloctyl Salicylate, Ethylhexyl Methoxycinnamate, Silica, 1,2-Hexanediol, Pentylene Glycol, Hydroxyethyl Urea, Cetearyl Olivate, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, Cetyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Xanthan Gum, Ethylhexylglycerin, Centella Asiatica Extract, Panthenol, Tocopherol, Centella Asiatica Flower/Leaf/Stem Extract, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Pyrus Malus (Apple) Fruit Extract

Section 51945-4 (51945-4)

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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