NDC Code(s) : 54111-139-50
Packager : Bentley Laboratories, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Brandless Lip Balm Coconut Broad Spectrum Zinc Oxide LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-139
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION0.6375 g in 4.25 g
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX(UNII: 2ZA36H0S2V)
COCONUT OIL(UNII: Q9L0O73W7L)
SOYBEAN OIL(UNII: 241ATL177A)
CASTOR OIL(UNII: D5340Y2I9G)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SHEA BUTTER(UNII: K49155WL9Y)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
TOCOPHEROL(UNII: R0ZB2556P8)
ARGAN OIL(UNII: 4V59G5UW9X)
BENZYL ALCOHOL(UNII: LKG8494WBH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54111-139-504.25 g in 1 TUBE Type 0: Not a Combination Product05/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 05/01/2018

LABELER - Bentley Laboratories, LLC(068351753)

PRINCIPAL DISPLAY PANEL

Brandless139-50Lbl

Peel label for drug facts info.

LIP BALMTM
Coconut
Broad Spectrum SPF 15
LIP BALMTM
NET WI 0.15 OZ (4.25g)

ACTIVE INGREDIENTS: Zinc Oxide 15%

DISTRIBUTED BY BRANDLESS, INC.
SAN FRANCISCO, CA 94129
BRANDLESS.COM • MADE IN USA

DRUG FACTS
Active Ingredients:                       Purpose:
Zinc Oxide 15%                         Sunscreen

Uses: 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 prevenl sunburn, not skin cancer orearly skin aging.

For external use only.

Do not use on damaged or broken skin.

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

Inactive Ingredients:
Beeswax, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Ricinus Communis (Castor) Seed, Oil, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Flavor, Polyhydroxystearic Acid,
Tocopherol, Argania Spinosa Kernel Oil, Benzyl Alcohol.

Other Information:
Protect this product from excessive heat and direct sun.

Report serious adverse event to Brandless, Inc., P.O. Box 472033, San Francisco, CA 94147

Questions or Comments?
1-888-811-7531 ● brandless,com