BRANDLESS LIP BALM COCONUT BROAD SPECTRUM 15%- zinc oxide lotion

Brandless Lip Balm Coconut Broad Spectrum by

Drug Labeling and Warnings

Brandless Lip Balm Coconut Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients: Zinc Oxide  15%

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

Do not use on damaged or broken skin.

STOP USE

Stop 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 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 INGREDIENT

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.

STORAGE AND HANDLING

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

OTHER SAFETY INFORMATION

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

QUESTIONS

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

Principal Display Package - Brandless SPF 15 Lip Balm

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

INGREDIENTS AND APPEARANCE

BRANDLESS LIP BALM COCONUT BROAD SPECTRUM  15%
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.6375 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
1	NDC: 54111-139-50	4.25 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2018

Labeler - Bentley Laboratories, LLC (068351753)