FDA.reportPublic FDA data

Sunfrog Ultra SPF 30 Lip Balm

Manufacturer
OraLabs
Effective date
2025-04-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:00:10

Label at a glance#

ProductSunfrog Ultra SPF 30 Lip Balm
Active ingredientOCTINOXATE, OXYBENZONE, PETROLATUM, OCTOCRYLENE, OCTISALATE
Label structure8 sections

Indications and uses

Prevents Sunburns

Dosage and administration

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate (7.5%), Octocrylene (7.0%), Oxybenzone (5.0%), Octisalate (5.0%), Petrolatum (30.0%)

Purpose

OTC - PURPOSE SECTION

Sunscreen, Sunscreen, Sunscreen, Sunscreen, Skin Protectant

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 only to prevent sunburn, not skin cancer 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 before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Synthetic Beeswax, Cetyl Alcohol, Mineral Oil, Paraffin, Polyethylene, Flavor, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Aluminum Hydroxide, Lanolin, Phenyl Trimethicone, Oleyl Alcohol, Isopropyl Lanolate, Isopropyl Myristate, BHT, Tocopheryl Acetate, Propyl paraben, Aloe Barbadensis Leaf Extract, Methylparaben, Sodium Saccharin.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunfrog Ultra SPF 30 Lip Balm
Sunfrog Ultra SPF 30 Lip Balm

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63645-165-012025-04-30C16284748780-12cef2736-a4b5-d83d-e063-dadaa90ab31fDrug Facts
63645-165-012025-01-30C16284748780-12cef2736-a4b5-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-165-01Sunfrog Ultra SPF 30 Lip Balm1 g in 1 CONTAINERSTICK13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-165SUNFROG ULTRA SPF 30 LIP BALM (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLY) STICK [ORALABS]3Current NDC, Legacy NDC, 1 package rows20250502_61299626-bf60-40e8-a2d3-4d4a99d8d15c.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
63645-16563645-165-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIGHT MINERAL OILN6K5787QVPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WHITE WAX7G1J5DA97FIACT
CETYL ALCOHOL936JST6JCNIACT
METHYLPARABENA2I8C7HI9TIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
PETROLATUM4T6H12BN9UACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

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
Sunfrog Ultra SPF 30 Lip BalmOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLYOraLabs61299626-bf60-40e8-a2d3-4d4a99d8d15c2025-04-30WarningsExact identifier
ndc (package): 63645-165-01
ndc (product): 63645-165
ndc11 (package): 63645016501
spl id: 3406aff4-68b5-4934-e063-6394a90aa85c
spl set id: 61299626-bf60-40e8-a2d3-4d4a99d8d15c

Reported adverse events (FAERS/openFDA)#

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