Pl-1849

Pl-1849
SPL v3
SPL
SPL Set ID 0a360f87-76cf-e6a7-e063-6294a90a07fb
Route
TOPICAL
Published
Effective Date 2025-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Levomenol Glycerin Water Vinylpyrrolidone/hexadecene Copolymer Trolamine Potassium Cetyl Phosphate Caprylyl Glycol Dimethicone Edetate Disodium Anhydrous Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-09

Description

Active ingredients avobenzone (3%) homosalate (10%) octisalate (5%) octocrylene (10%)


Medication Information

Warnings and Precautions

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Indications and Usage

Use • Helps prevent sunburn

Dosage and Administration

Directions

  • Apply liberally for 15 minutes before sun exposure and as needed.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months of age: Ask a doctor.
Description

Active ingredients avobenzone (3%) homosalate (10%) octisalate (5%) octocrylene (10%)

Section 50565-1

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

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

Inactive ingredients

Acrylate/Beheneth-25 Methacrylate Copolymer, Bisabolol, Caprylyl Glycol, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Phenoxyethanol, Potassium Cetyl Phosphate, Triethanolamine, VP/Hexadecene Copolymer, Water

Section 51945-4

Sunscreen

SPF30

Net 1 FL OZ (29.6ML)

Dist. by Broder Bros., Co. dba Primeline Gaffney, SC 29341

Made in China

Section 53413-1

Questions? 1-800-873-7746 M-F 8am-5pm EST

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredients

avobenzone (3%)

homosalate (10%)

octisalate (5%)

octocrylene (10%)

Other Information

Protect the product in this container from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Use • Helps prevent sunburn

Dosage and Administration (34068-7)

Directions

  • Apply liberally for 15 minutes before sun exposure and as needed.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months of age: Ask a doctor.
Warnings and Precautions (34071-1)

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 right away.

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)

Inactive ingredients

Acrylate/Beheneth-25 Methacrylate Copolymer, Bisabolol, Caprylyl Glycol, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Phenoxyethanol, Potassium Cetyl Phosphate, Triethanolamine, VP/Hexadecene Copolymer, Water

Section 51945-4 (51945-4)

Sunscreen

SPF30

Net 1 FL OZ (29.6ML)

Dist. by Broder Bros., Co. dba Primeline Gaffney, SC 29341

Made in China

Section 53413-1 (53413-1)

Questions? 1-800-873-7746 M-F 8am-5pm EST

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

avobenzone (3%)

homosalate (10%)

octisalate (5%)

octocrylene (10%)

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)