FDA.reportPublic FDA data

100% Pure Sweet Mint Lip Balm

Manufacturer
Purity Cosmetics | Eco Lips, Inc.
Effective date
2017-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:16:39

Label at a glance#

Product100% Pure Sweet Mint Lip Balm SPF 15
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: after 40 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 this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the ...

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 8.7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

WARNINGS SECTION

  • ​For external use only
  • Do not use ​on damaged or broken skin
  • ​When using this product​ keep out of eyes. Rinse with water to remove.
  • ​Stop use and ask a doctor ​if rash occurs.

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply: after 40 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 this 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-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.

Other Ingredients

INACTIVE INGREDIENT SECTION

*Cerba Alba (Beeswax), Fair Trade Certified™ *Theobroma Cacao (Cocoa) Seed Butter, *Cocos Nucifera (Coconut) Oil, *Rincus Communis (Castor) Seed Oil, * Vanilla Flavor, *Helianthus Annus (Sunflower) Seed Oil, *Persea Gratissima (Avocado) Oil, Mixed Tocopherols (Vitamin E), *Mentha Piperita (Peppermint) Essential Oil, Calophyllum Inophyllum (Tamanu) Oil, Hippophae Rhamnoides (Sea Buckthorn) Fruit Oil, Calendula Officinalis (Calendula) Extract. *Certified Organic

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

100% Pure Sweet Mint Lip Balm SPF 15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Representative ImageRepresentative Image

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130899738011262GTIN-13: 0899738011262
EAN-13: 0899738011262
GTIN-12: 899738011262
UPC-A: 899738011262
GTIN storage (14 digits): 00899738011262		SPF15SweetMintLipBalm.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52667-005-012024-12-05C16284748780-19d75b9d1-062d-f424-e053-dadaa90a57ce100% Pure Sweet Mint Lip Balm SPF 15
52667-005-012020-01-31C16284748780-19d75b9d1-062d-f424-e053-dadaa90a57ce100% Pure Sweet Mint Lip Balm SPF 15

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52667-00552667-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
CASTOR OILD5340Y2I9GIACT
COCOA BUTTER512OYT1CRRIACT
AVOCADO OIL6VNO72PFC1IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ARGAN OIL4V59G5UW9XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ZINC OXIDESOI2LOH54ZACTIM
TAMANU OILJT3LVK84A1IACT
ALOE VERA LEAFZY81Z83H0XIACT
MENTHA PIPERITA79M2M2UDA9IACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
COCONUT OILQ9L0O73W7LIACT

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
2877dfee-4e0f-2431-e063-6294a90aceca4e76e036-5a78-5c06-e054-00144ff8d46c2024-12-04WarningsExact identifier
spl set id: 4e76e036-5a78-5c06-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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