FDA.reportPublic FDA data

Brandless Coconut Lip Balm SPF 15

Manufacturer
Brandless
Effective date
2018-10-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:06

Label at a glance#

ProductBrandless Coconut Lip Balm SPF 15
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15%

Purpose: Sunscreen

Uses

OTC - PURPOSE 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 prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

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

Directions

INSTRUCTIONS FOR USE SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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?

SPL UNCLASSIFIED SECTION

1-888-811-7531

Brandless.com

Company information

SPL UNCLASSIFIED SECTION

Distributed by Brandless, Inc. San Francisco, CA 94129

Brandless.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Brandless Lip Balm

Coconut

Broad Spectrum SPF 15

NET WT 0.15 OZ (4.25g)

lip balmlip balm

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72599-2376-12021-01-29C16284748780-1ba0f9c33-0eb9-a910-e053-dadaa90a0b85Brandless Coconut Lip Balm SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72599-2376-1Brandless Coconut Lip Balm SPF 154.25 g in 1 TUBE, WITH APPLICATORLIPSTICK4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72599-2376BRANDLESS COCONUT LIP BALM SPF 15 (ZINC OXIDE) LIPSTICK [BRANDLESS]1Legacy NDC, 1 package rows20181027_79255810-60ba-c84c-e053-2991aa0a062b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72599-237672599-2376-1

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 OXIDESOI2LOH54ZACTIB
CASTOR OILD5340Y2I9GIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SHEA BUTTERK49155WL9YIACT
ARGAN OIL4V59G5UW9XIACT
BENZYL ALCOHOLLKG8494WBHIACT
YELLOW WAX2ZA36H0S2VIACT
COCONUT OILQ9L0O73W7LIACT
SOYBEAN OIL241ATL177AIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TOCOPHEROLR0ZB2556P8IACT

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
79255810-60bb-c84c-e053-2991aa0a062b79255810-60ba-c84c-e053-2991aa0a062b2018-10-26WarningsExact identifier
spl id: 79255810-60bb-c84c-e053-2991aa0a062b
spl set id: 79255810-60ba-c84c-e053-2991aa0a062b

Reported adverse events (FAERS/openFDA)#

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