FDA.reportPublic FDA data

Sunscreen Lip Balm SPF 30

Manufacturer
Salt and Stone LLC
Effective date
2019-06-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:20:51

Label at a glance#

ProductSunscreen Lip Balm SPF 30
Active ingredientZINC OXIDE
Label structure7 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 the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection ...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Non-Nano Zinc Oxide 8%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Helps Prevent Sunburn

Warnings:

WARNINGS SECTION

• For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

• Rash occurs

When using this product

OTC - WHEN USING SECTION

• Keep out of eyes. Rinse with water to remove.

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.

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 the 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 10am - 2pm . Wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Prunus Amygdalus Dulcis (Sweet Almond) Oil*, Butyrospermum Parkii (Shea) Butter*, Cera Alba (Beeswax)*, Simmondsia Chinensis (Jojoba) Seed Oil*, Caprylic/capric Triglyceride, Euphorbia Cerifera (Candelilla) Wax*, Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil*, Copernicia Cerifera (Carnauba) Wax*, Tocopherol, Bisabolol, Glyceryl Caprylate, Isostearic Acid, Lecithin, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Glyceryl Undecylenate. *Organic Ingredient.

Other Information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130711221983453GTIN-13: 0711221983453
EAN-13: 0711221983453
GTIN-12: 711221983453
UPC-A: 711221983453
GTIN storage (14 digits): 00711221983453		Label.jpg

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71585-12071585-120-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALMOND OIL66YXD4DKO9IACT
SHEA BUTTERK49155WL9YIACT
WHITE WAX7G1J5DA97FIACT
JOJOBA OIL724GKU717MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CANDELILLA WAXWL0328HX19IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ARGAN OIL4V59G5UW9XIACT
CARNAUBA WAXR12CBM0EIZIACT
TOCOPHEROLR0ZB2556P8IACT
LEVOMENOL24WE03BX2TIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
ISOSTEARIC ACIDX33R8U0062IACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
ZINC OXIDESOI2LOH54ZACTIM

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
c3cd9f3c-a472-9a32-e053-2995a90a4f9df67de40b-1e6b-444e-a771-a75f106b43202021-06-02WarningsExact identifier
spl set id: f67de40b-1e6b-444e-a771-a75f106b4320

Reported adverse events (FAERS/openFDA)#

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