FDA.reportPublic FDA data

Curology The Lip Balm Broad Spectrum SPF 30 Sunscreen

Manufacturer
Curology Inc.
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:41:36

Label at a glance#

ProductCurology The Lip Balm Broad Spectrum SPF 30 Sunscreen
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply generously 15 minutes before sun exposure. Reapply every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children undre 6 months of age: Ask a doctor 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: Sun Protection Meas...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.4%

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously 15 minutes before sun exposure.
  • Reapply every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children undre 6 months of age: Ask a doctor
  • 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: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Diisostearyl Dimer Dilinoleate, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Triisostearin, Helianthus Annuus (Sunflower) Seed Oil, Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Ozokerite, Ricinus Communis (Castor) Seed Oil, Jojoba Esters, Butyrospermum Parkii (Shea) Butter, Sucrose Tetrastearate Triacetate, Caprylic/Capric Triglyceride, Tocopherol, Tocopheryl Acetate, Caprylyl Glycol, 1,2-Hexanediol, Triethoxycaprylylsilane, Ethyl Ferulate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner PackageBoxBox

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130382575000013GTIN-13: 0382575000013
EAN-13: 0382575000013
GTIN-12: 382575000013
UPC-A: 382575000013
GTIN storage (14 digits): 00382575000013		Outer Package.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82575-034-01Curology The Lip Balm Broad Spectrum SPF 30 Sunscreen4 g in 1 TUBESTICK43
82575-034-01Curology The Lip Balm Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONSTICK13

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82575-03482575-034-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIISOSTEARYL DIMER DILINOLEATE04P17590APIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
CANDELILLA WAXWL0328HX19IACT
TRIISOSTEARIN71503RH8KGIACT
SUNFLOWER OIL3W1JG795YIIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE65954KGO9QIACT
CASTOR OILD5340Y2I9GIACT
SHEA BUTTERK49155WL9YIACT
SUCROSE TETRASTEARATE TRIACETATE1K7LBQ045NIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYL FERULATE5B8915UELWIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22023-11-14full-release2026-06-01 00:02:05

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
Curology The Lip Balm Broad Spectrum SPF 30 SunscreenZINC OXIDECurology Inc.e441b13f-cb58-457f-e053-2a95a90adab92025-10-15WarningsExact identifier
ndc (package): 82575-034-01
ndc (product): 82575-034
ndc11 (package): 82575003401
spl id: 4138bbda-3f96-2b3f-e063-6394a90a80cc
spl set id: e441b13f-cb58-457f-e053-2a95a90adab9

Reported adverse events (FAERS/openFDA)#

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