FDA.reportPublic FDA data

SPF 15 - Zinc Oxide Lip Balm

Manufacturer
OraLabs
Effective date
2025-04-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:59:31

Label at a glance#

ProductSPF 15 - Zinc Oxide Lip Balm
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Prevents Sunburns

Dosage and administration

Apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging • To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in t...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (10.0%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Prevents Sunburns

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 to prevent sunburn, skin cancer and/or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure • reapply: after 80 minutes

of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun

Protection Measures.Spending time in the sun increases your risk of skin cancer and

early skin aging • To decrease the risk, regularly use a sunscreen with a broad spectrum

SPF of 15 or higher and other sun protection measures including: limit time in the sun,

especially from 10 a.m. -2 p.m. • wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Behenyl Behenate, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Caprylic/CapricTriglyceride, Flavor, Euphorbia Cerifera (Candelilla) Wax, Persea Gratissima (Avocado) Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea Butter),Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Helianthus Annuus(Sunflower) Seed Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Melaleuca

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts Box - Back of Card
Drug Facts Box - Back of Card

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63645-182-012025-04-22C16284748780-12cef2736-a47c-d83d-e063-dadaa90ab31fDrug Facts
63645-182-012025-01-30C16284748780-12cef2736-a47c-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-182-01SPF 15 - Zinc Oxide Lip Balm4 g in 1 CONTAINERSTICK42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-182SPF 15 - ZINC OXIDE LIP BALM (ZINC OXIDE) STICK [ORALABS]2Current NDC, 1 package rows20250424_8c293e38-83de-404a-b667-01c2e4b99072.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63645-18263645-182-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
WHITE WAX7G1J5DA97FIACT
ALMOND OIL66YXD4DKO9IACT
CASTOR OILD5340Y2I9GIACT
ZINC OXIDESOI2LOH54ZACTIB

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
SPF 15 - Zinc Oxide Lip BalmZINC OXIDEOraLabs8c293e38-83de-404a-b667-01c2e4b990722025-04-22WarningsExact identifier
ndc (package): 63645-182-01
ndc (product): 63645-182
ndc11 (package): 63645018201
spl id: 33657059-315e-02d5-e063-6294a90a6dcd
spl set id: 8c293e38-83de-404a-b667-01c2e4b99072

Reported adverse events (FAERS/openFDA)#

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