84326-524

84326-524
SPL v2
SPL
SPL Set ID 262450f0-c4a1-dcca-e063-6394a90ae3cd
Route
topical
Published
Effective Date 2024-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (1.995 g) avobenzone (0.525 g) octisalate (0.945 g) homosalate
Inactive Ingredients
dimethylsilanol hyaluronate sodium acetylated hyaluronate hyaluronate sodium hyaluronic acid butyloctyl salicylate .alpha.-tocopherol, d- butylene glycol ethylhexylglycerin water centella asiatica triterpenoids 1,2-hexanediol ethylhexyl palmitate allantoin synthetic wax (1900 mw) dicaprylyl carbonate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-11-05
Description

Avobenzone 2.5% Homosalate 9.5% Octisalate 4.5% Octocrylene 9.5%

Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Avobenzone 2.5%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 9.5%

Indications and Usage

● 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

Directions

● Apply liberally 15 minutes before sun exposure.

● Use a water resistant sunscreen if swimming or sweating.

● Reapply 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses.

Description

Avobenzone 2.5% Homosalate 9.5% Octisalate 4.5% Octocrylene 9.5%

Section 50565-1

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

Section 50566-9

and ask a doctor if rash occurs.

Section 50567-7

this product ● keep out of eyes. Rinse with water to remove.

Section 50570-1

● on damaged or broken skin

Section 51727-6

Ethylhexyl Palmitate, Synthetic Wax, Butyloctyl Salicylate, Dicaprylyl Carbonate, Ethylhexylglycerin, Water, Tocopherol, Allantoin, Butylene Glycol, 1,2-Hexanediol, Centella Asiatica Extract, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Sodium Hyaluronate, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate

Section 51945-4

Section 55105-1

Sunscreen

Section 60561-8

● Protect this product from excessive heat and direct sun.

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Avobenzone 2.5%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 9.5%

Indications and Usage (34067-9)

● 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.

● Use a water resistant sunscreen if swimming or sweating.

● Reapply 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

this product ● keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

● on damaged or broken skin

Section 51727-6 (51727-6)

Ethylhexyl Palmitate, Synthetic Wax, Butyloctyl Salicylate, Dicaprylyl Carbonate, Ethylhexylglycerin, Water, Tocopherol, Allantoin, Butylene Glycol, 1,2-Hexanediol, Centella Asiatica Extract, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Sodium Hyaluronate, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 60561-8 (60561-8)

● Protect this product from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:14.484293 · Updated: 2026-03-14T23:10:29.645873