Pc186

Pc186
SPL v3
SPL
SPL Set ID 0a387641-3b87-38e0-e063-6294a90a81b3
Route
TOPICAL
Published
Effective Date 2021-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-01-21 Until 2026-06-30

Description

Active ingredient 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 ingredient 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 2 FL OZ (60 ML)

Made in China

Dist. By Broder Bros. Co., dba alphabroder

Gaffney, SC 29341

Lot no: Use by:

Section 53413-1

Questions?

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

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredient

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 2 FL OZ (60 ML)

Made in China

Dist. By Broder Bros. Co., dba alphabroder

Gaffney, SC 29341

Lot no: Use by:

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 ingredient

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)