SUNSCREEN SPF30- avobenzone, homosalate, octisalate, octocrylene lotion

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]

Drug Facts

ACTIVE INGREDIENT

Active ingredients

avobenzone (3%)

homosalate (10%)

octisalate (5%)

octocrylene (10%)

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Use Helps prevent sunburn

WARNINGS

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

Do not use on damaged or broken skin.

STOP USE

Stop use and ask a doctor if rash occurs.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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.

INACTIVE INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

Sunscreen

SPF30

Net 1 FL OZ (29.6ML)

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

Made in China

INGREDIENTS AND APPEARANCE

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

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

Labeler - Broder Bros Prime Line (107044246)