84326-724

84326-724
SPL v2
SPL
SPL Set ID 29fc0c2b-8d10-8704-e063-6394a90ad504
Route
TOPICAL
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (9.5 g) Avobenzone (2.8 g) Octisalate (4.8 g) Homosalate (7.3 g)
Inactive Ingredients
Madecassic Acid Alcohol Benzyl Glycol Ethylhexylglycerin Ethyl Hexanediol Asiaticoside Asiatic Acid Sodium Acetylated Hyaluronate Hyaluronic Acid Butyloctyl Salicylate Butylene Glycol Water 1,2-hexanediol Sodium Hyaluronate Isopropyl Myristate Acrylates/octylacrylamide Copolymer (40000 Mw) Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-23
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

● Spray liberally and spread evenly by hand 15 minutes before sun exposure.

● Apply to all skin exposed to the sun.

● Do not spray directly into face.

● Spray on hands and then apply to face. Rub in.

● If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

● Do not apply in windy conditions.

● 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

Alcohol, Isopropyl Myristate, Butyloctyl Salicylate, Acrylates/Octylacrylamide Copolymer, Water, Benzyl Glycol, Ethylhexylglycerin, 1,2-Hexanediol, Glycerin, Butylene Glycol, Sodium Hyaluronate, Ethyl Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Aslatic Acid, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Fragrance

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 2.5%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 9.5%

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

● Spray liberally and spread evenly by hand 15 minutes before sun exposure.

● Apply to all skin exposed to the sun.

● Do not spray directly into face.

● Spray on hands and then apply to face. Rub in.

● If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

● Do not apply in windy conditions.

● 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)

Alcohol, Isopropyl Myristate, Butyloctyl Salicylate, Acrylates/Octylacrylamide Copolymer, Water, Benzyl Glycol, Ethylhexylglycerin, 1,2-Hexanediol, Glycerin, Butylene Glycol, Sodium Hyaluronate, Ethyl Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Aslatic Acid, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Fragrance

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%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:01.160127 · Updated: 2026-03-14T23:13:06.603726