FDA.reportPublic FDA data

Brandless Lip Balm Coconut Broad Spectrum

Manufacturer
Bentley Laboratories, LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:17:34

Label at a glance#

ProductBrandless Lip Balm Coconut Broad Spectrum 15%
Active ingredientZINC OXIDE
Label structure14 sections

Indications and uses

Helps prevent sunburn.

Storage and handling

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

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Zinc Oxide  15%

Purpose  Sunscreen

OTC - PURPOSE SECTION

Helps prevent sunburn.

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

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

OTC - QUESTIONS SECTION

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

Principal Display Package - Brandless SPF 15 Lip Balm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Brandless139-50LblBrandless139-50Lbl

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54111-139-502022-06-27C16284748780-19d75b9d0-9946-f424-e053-dadaa90a57ceBrandless Lip Balm Coconut Broad Spectrum SPF 15
54111-139-502020-01-31C16284748780-19d75b9d0-9946-f424-e053-dadaa90a57ceBrandless Lip Balm Coconut Broad Spectrum SPF 15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-139BRANDLESS LIP BALM COCONUT BROAD SPECTRUM 15% (ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]4Legacy NDC20231220_14ac6086-4e2a-400b-aab7-1ffa6115cf6d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-13954111-139-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
YELLOW WAX2ZA36H0S2VIACT
COCONUT OILQ9L0O73W7LIACT
SOYBEAN OIL241ATL177AIACT
CASTOR OILD5340Y2I9GIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SHEA BUTTERK49155WL9YIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TOCOPHEROLR0ZB2556P8IACT
ARGAN OIL4V59G5UW9XIACT
BENZYL ALCOHOLLKG8494WBHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
45f311c2-5b22-1497-e063-6294a90a9ab214ac6086-4e2a-400b-aab7-1ffa6115cf6d2025-12-14WarningsExact identifier
spl set id: 14ac6086-4e2a-400b-aab7-1ffa6115cf6d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.