SPL v2
SPL
SPL Set ID 3a2a74f2-9fed-808f-e063-6294a90a410c
Route
TOPICAL
Published
Effective Date 2025-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (9 g) Homosalate (7 g) Butyl Methoxydibenzoylmethane (2.7 g) Ethylhexyl Salicylate (4.5 g)
Inactive Ingredients
Xanthan Gum Hydroxyacetophenone Tromethamine Sodium Acetylated Hyaluronate Potassium Cetyl Phosphate Butyloctyl Salicylate Sodium Acrylates Crosspolymer-2 Pentylene Glycol Cetyl Alcohol Cetearyl Olivate Carbomer Lavandula Angustifolia (lavender) Oil Glyceryl Glucoside Hyaluronic Acid 1,2-hexanediol Sorbitan Olivate Glyceryl Stearate Citrate Butylene Glycol Polyglyceryl-3 Distearate Citrus Aurantium Dulcis (orange) Peel Oil Sodium Phytate Glycerin Water Ethylhexyl Methoxycrylene

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-25

Description

Directions • Apply liberally 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating • 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 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.

Purpose

Sunscreen


Medication Information

Warnings and Precautions

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

Purpose

Sunscreen

Dosage and Administration



Directions

• Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating

• 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 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.

Description

Directions • Apply liberally 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating • 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 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.

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.

Section 50565-1

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

Section 51727-6



Water, Butyloctyl Salicylate, Butylene Glycol, Ethylhexyl Methoxycrylene, Sodium Acrylates Crosspolymer-2, Polyglyceryl-3 Distearate, 1,2-Hexanediol, Pentylene Glycol, Cetearyl Olivate, Potassium Cetyl Phosphate, Sorbitan Olivate, Cetyl Alcohol, Hydroxyacetophenone, Citrus Aurantium Dulcis (Orange) Peel Oil, Carbomer, Tromethamine, Lavandula Angustifolia (Lavender) Oil, Xanthan Gum, Glyceryl Stearate Citrate, Sodium Phytate, Glucosylrutin, Glyceryl Glucoside, Equisetum Arvense Extract, Lycopodium Clavatum Extract, Sodium Hyaluronate, Glycerin, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Sodium Acetylated Hyaluronate

Section 51945-4

Other Information

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


Structured Label Content

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.

Dosage and Administration (34068-7)



Directions

• Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating

• 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 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.

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)



Water, Butyloctyl Salicylate, Butylene Glycol, Ethylhexyl Methoxycrylene, Sodium Acrylates Crosspolymer-2, Polyglyceryl-3 Distearate, 1,2-Hexanediol, Pentylene Glycol, Cetearyl Olivate, Potassium Cetyl Phosphate, Sorbitan Olivate, Cetyl Alcohol, Hydroxyacetophenone, Citrus Aurantium Dulcis (Orange) Peel Oil, Carbomer, Tromethamine, Lavandula Angustifolia (Lavender) Oil, Xanthan Gum, Glyceryl Stearate Citrate, Sodium Phytate, Glucosylrutin, Glyceryl Glucoside, Equisetum Arvense Extract, Lycopodium Clavatum Extract, Sodium Hyaluronate, Glycerin, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Sodium Acetylated Hyaluronate

Section 51945-4 (51945-4)

Purpose

Sunscreen

Other Information

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


Advanced Ingredient Data


Raw Label Data

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