83447-012

83447-012
SPL v1
SPL
SPL Set ID 3a7c1345-532f-b38f-e063-6394a90a5245
Route
CUTANEOUS
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ethylhexyl Salicylate (8 g) Homosalate (5 g) Ethylhexyl Methoxycinnamate (3 g) Octocrylene (10 g)
Inactive Ingredients
Peg/ppg-17/6 Copolymer Hyaluronic Acid Ferrous Oxide Betaine Tocopherol Laureth-7 Phenoxyethanol Aqua Glycerin Propylene Glycol Collagen, Soluble, Fish Skin Caprylic/capric Triglyceride Ascorbic Acid Peach C13-14 Isoparaffin Ammonium Acryloyldimethyltaurate/vp Copolymer Polyacrylamide (1500 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-22

Description

Octocrylene 10% Ethylhexyl Salicylate 8% Homosalate 5% Ethylhexyl Methoxycinnamate 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octocrylene 10% Ethylhexyl Salicylate 8% Homosalate 5% Ethylhexyl Methoxycinnamate 3%

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 51945-4

Stop Use

Stop use and ask a doctor if rash occurs.

Warnings

For external use only.

Directions

Apply liberally 15 minutes before sun exposure. Reapply every two hours. Water-

resistant up to 40 minutes.

Do Not Use

Do not use on damaged or broken skin.

Keep Out Of

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

Other Information

Store at room temperature

Active Ingredients

Octocrylene 10%

Ethylhexyl Salicylate 8%

Homosalate 5%

Ethylhexyl Methoxycinnamate 3%

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Collagen, Caprylic/Capric Triglyceride,

Vitamin C, PEG/PPG- 17 / 6 Copolymer, Hyaluronic Acid,

Betaine, Ammonium Acryloyldimethyltaurate/vp Copolymer,

Tocopherol, Polyacrylamide, lron oxides, C13- 14 Isoparaffin,

Laureth-7, Sodium Acrylate/Sodium Acryloyldimethyl Taurate

Copolymer, Fragrance, Phenoxyethanol.

When Using This Product

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


Structured Label Content

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 51945-4 (51945-4)

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs.

Warnings

For external use only.

Directions

Apply liberally 15 minutes before sun exposure. Reapply every two hours. Water-

resistant up to 40 minutes.

Do Not Use (Do not use)

Do not use on damaged or broken skin.

Keep Out Of (Keep out of)

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

Other Information (Other information)

Store at room temperature

Active Ingredients (Active ingredients)

Octocrylene 10%

Ethylhexyl Salicylate 8%

Homosalate 5%

Ethylhexyl Methoxycinnamate 3%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene Glycol, Collagen, Caprylic/Capric Triglyceride,

Vitamin C, PEG/PPG- 17 / 6 Copolymer, Hyaluronic Acid,

Betaine, Ammonium Acryloyldimethyltaurate/vp Copolymer,

Tocopherol, Polyacrylamide, lron oxides, C13- 14 Isoparaffin,

Laureth-7, Sodium Acrylate/Sodium Acryloyldimethyl Taurate

Copolymer, Fragrance, Phenoxyethanol.

When Using This Product (When using this product)

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


Advanced Ingredient Data


Raw Label Data

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