84326-624

84326-624
SPL v2
SPL
SPL Set ID 26345203-3393-60ba-e063-6394a90a7e92
Route
TOPICAL
Published
Effective Date 2024-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (1.71 g) Avobenzone (0.45 g) Octisalate (0.81 g) Homosalate
Inactive Ingredients
Centella Asiatica Triterpenoids Dimethylsilanol Hyaluronate Sodium Acetylated Hyaluronate Hyaluronate Sodium Hyaluronic Acid Butyloctyl Salicylate Tocopherol Butylene Glycol Ethylhexylglycerin Water 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

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 55106-9

Avobenzone 2.5%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 9.5%

Section 60561-8

● Protect this product from excessive heat and direct sun.

Structured Label Content

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.

Warnings and Precautions (34071-1)

For external use only

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 55106-9 (55106-9)

Avobenzone 2.5%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 9.5%

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: 2026-02-15T12:04:14.410178 · Updated: 2026-03-14T23:13:07.898715