LIP BALM SPF15- octocrylene, octisalate stick

Lip Balm SPF15 by

Drug Labeling and Warnings

Lip Balm SPF15 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
Octocrylene 8%
Octisalate 4%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses Helps prevent sunburn.

WARNINGS

Warnings
For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs

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

DOSAGE & ADMINISTRATION

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

Other information

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

INACTIVE INGREDIENT

Inactive ingredients
Beeswax, Butyrospermum Parkii (Shea) Butter, Fragrance, Methylparaben, Microcrystalline Wax, Mineral Oil, Ozokerite Wax, Petrolatum, Polyisobutylene, Propylparaben, Tocopherol

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

Lip Balm SPF15
Sunscreen

Net weight .15 oz.

Dist. By Broder Bros. Co., dba
alphabroder
Gaffney, SC 29341
Made in China

INGREDIENTS AND APPEARANCE

LIP BALM SPF15 
octocrylene, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71513-608
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
YELLOW WAX (UNII: 2ZA36H0S2V)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71513-608-80	4 g in 1 CYLINDER; Type 0: Not a Combination Product	01/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/21/2021

Labeler - Broder Bros Prime Line (107044246)