Label: BRANDLESS LIP BALM COCONUT BROAD SPECTRUM 15%- zinc oxide lotion
- NDC Code(s): 54111-139-50
- Packager: Bentley Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2023
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- DRUG FACTS
- Purpose Sunscreen
- Uses
- Warnings
- DO NOT USE
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- OTHER SAFETY INFORMATION
- QUESTIONS
-
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 USADRUG FACTS
Active Ingredients: Purpose:
Zinc Oxide 15% SunscreenUses: 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 lotionProduct 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 Drug M020 05/01/2018 Labeler - Bentley Laboratories, LLC (068351753)