Sunscreen SPF30 by Broder Bros Prime Line PL-1849

Sunscreen SPF30 by

Drug Labeling and Warnings

Sunscreen SPF30 by is a Otc medication manufactured, distributed, or labeled by Broder Bros Prime Line. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNSCREEN SPF30- avobenzone, homosalate, octisalate, octocrylene lotion 
Broder Bros Prime Line

----------

PL-1849

Drug Facts

Active ingredients

avobenzone (3%)

homosalate (10%)

octisalate (5%)

octocrylene (10%)

Purpose

Sunscreen

Use Helps prevent sunburn

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.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

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

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.

Inactive ingredients

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

Other information

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

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

Sunscreen

SPF30

Net 1 FL OZ (29.6ML)

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

Made in China

SUNSCREEN SPF30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71513-708
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
TROLAMINE (UNII: 9O3K93S3TK)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71513-708-01	29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021	09/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021	09/30/2023

Labeler - Broder Bros Prime Line (107044246)

Revised: 10/2024

Document Id: 25a84b2e-dd62-2662-e063-6394a90af3e3

34390-5

Set id: 0a360f87-76cf-e6a7-e063-6294a90a07fb

Version: 2

Effective Time: 20241029