73071-101

73071-101
SPL v2
SPL
SPL Set ID 2f1ca6e0-f689-57c7-e063-6394a90a3da5
Route
TOPICAL
Published
Effective Date 2025-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (2.4 g) Homosalate (3.6 g) Octocrylene (4.9 g) Avobenzone (1.5 g)
Inactive Ingredients
Arginine Sodium Acetylated Hyaluronate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Squalane Cetearyl Alcohol Niacinamide Adenosine Butylene Glycol Dimethylsilanol Hyaluronate Panthenol Dipropylene Glycol Silica Pentylene Glycol Ethylhexylglycerin 1,2-hexanediol Sorbitan Olivate Benzyl Glycol Ganoderma Lucidum Stem Xanthan Gum Sodium Hyaluronate Water Isohexadecane Mentha Piperita (peppermint) Oil Hyaluronic Acid Cetearyl Glucoside

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-26
Description

Octocrylene 9.8% Homosalate 7.2% Octisalate 4.8% Avobenzone 3.0%

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. ■ 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 value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses.

Description

Octocrylene 9.8% Homosalate 7.2% Octisalate 4.8% Avobenzone 3.0%

Section 50565-1

■ Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Section 50566-9

Stop use and ask a doctor if ■ rash occurs.

Section 50567-7

When using this product ■ keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use ■ on damaged or broken skin.

Section 51727-6

Water(Aqua), Isohexadecane, Dipropylene Glycol, Silica, Niacinamide, Cetearyl Glucoside, Sorbitan Olivate, Benzyl Glycol, Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Cetearyl Alcohol, Xanthan Gum, Pentylene Glycol, Adenosine, Ethylhexylgly cerin, Mentha Piperita (Peppermint) Oil, Squalane, Ganoderma Lucidum (Mushroom) Stem Extract, Butylene Glycol, 1,2-Hexanediol, 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

Octocrylene 9.8%

Homosalate 7.2%

Octisalate 4.8%

Avobenzone 3.0%

Section 60561-8

■ protect this product in this container 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. ■ 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 value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10a.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)

■ Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Section 50566-9 (50566-9)

Stop use and ask a doctor if ■ rash occurs.

Section 50567-7 (50567-7)

When using this product ■ keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use ■ on damaged or broken skin.

Section 51727-6 (51727-6)

Water(Aqua), Isohexadecane, Dipropylene Glycol, Silica, Niacinamide, Cetearyl Glucoside, Sorbitan Olivate, Benzyl Glycol, Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Cetearyl Alcohol, Xanthan Gum, Pentylene Glycol, Adenosine, Ethylhexylgly cerin, Mentha Piperita (Peppermint) Oil, Squalane, Ganoderma Lucidum (Mushroom) Stem Extract, Butylene Glycol, 1,2-Hexanediol, 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)

Octocrylene 9.8%

Homosalate 7.2%

Octisalate 4.8%

Avobenzone 3.0%

Section 60561-8 (60561-8)

■ protect this product in this container from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:47.638193 · Updated: 2026-03-14T23:13:06.603726