FDA.reportPublic FDA data

ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen

Manufacturer
Absolutely Natural
Effective date
2024-09-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:23:49

Label at a glance#

ProductABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen
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 of age: Ask a doctor Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection me...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 8.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• Helps prevent sunburn

Warnings

WARNINGS SECTION

• 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.

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.

Directions

DOSAGE & ADMINISTRATION 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 of age: Ask a doctor Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10a.m - 2p.m • wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Sunflower Oil, Beeswax, Olive Oil*, Flavor, Tocopherol, Soybean Oil, Aloe Extract, Canola Oil.

*Organic Ingredient

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Pineapple Flavor

Pineapple Mineral Lip Balm

Made in the USA with responsibly-sourced global ingredients

Dist. by: Absolutely Natural, 640 Atlantis Rd, Melbourne, FL 32904, (800) 848-7623

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LipBalmS-2LipBalmS-2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70793-043-15ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen4.25 g in 1 TUBESTICK4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70793-043ABSOLUTELY NATURAL LIP BALM BROAD SPECTRUM SPF 15 SUNSCREEN (ZINC OXIDE) STICK [ABSOLUTELY NATURAL]1Current NDC, 1 package rows20241010_eb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70793-04370793-043-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
SUNFLOWER OIL3W1JG795YIIACT
WHITE WAX7G1J5DA97FIACT
OLIVE OIL6UYK2W1W1EIACT
TOCOPHEROLR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT
ALOE VERA LEAFZY81Z83H0XIACT
CANOLA OIL331KBJ17RKIACT

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
ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 SunscreenZINC OXIDEAbsolutely Naturaleb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea2024-09-23WarningsExact identifier
ndc (package): 70793-043-15
ndc (product): 70793-043
ndc11 (package): 70793004315
spl id: c0f6f646-3d04-4cae-b097-150c89aa0770
spl set id: eb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea

Reported adverse events (FAERS/openFDA)#

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