FDA.reportPublic FDA data

Curology the sunscreen broad spectrum SPF 30

Manufacturer
Curology Inc.
Effective date
2023-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:05

Label at a glance#

ProductCurology the sunscreen broad spectrum SPF 30
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

apply liberally 15 minutes before sun exposure. reapply: immediately after towel drying  at least every 2 hours 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: Sun Protection Measures. limit time in the sun, especially from 10 a.m.-2 p.m. wear lon...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure.
  • reapply:
  • immediately after towel drying 
  • at least every 2 hours
  • 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: Sun Protection Measures.
  • 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 information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Dimethicone, Propylene Glycol, C12-15 Alkyl Benzoate, Sorbitan Oleate Decylglucoside Crosspolymer, Cetearyl Alcohol, Argania Spinosa Kernel Oil, Ammonium Acryloyldimethyltaurate/VP Copolymer, Tocopheryl Acetate, Glycerin, Squalane, Butyrospermum Parkii (Shea Butter) Extract, Polyster-5, Caprylyl/Capryl Glucoside, Coco-Glucosdie, C14-22 Alcohols, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Triethoxycaprylylsilane, Ethyl Ferulate, C12-20 Alkyl Glucoside, Bisabolol, Sodium Chloride, Phospholipids, Gluconolactone, Benzyl Alcohol, Sodium Benzoate, Chlorophensin, Sorbic Acid, Urea, Phenoxyethanol, Ethylhexylglycerin

Package Labeling:20ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

Package Labeling:40ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package3Outer Package3Inner Package3Inner Package3

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82575-032-00Curology the sunscreen broad spectrum SPF 301 in 1 CARTONCREAM12
82575-032-00Curology the sunscreen broad spectrum SPF 3040 mL in 1 TUBECREAM402
82575-032-01Curology the sunscreen broad spectrum SPF 301 in 1 CARTONCREAM12
82575-032-01Curology the sunscreen broad spectrum SPF 3020 mL in 1 TUBECREAM202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82575-032CUROLOGY THE SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) CREAM [CUROLOGY INC.]2Current NDC, Legacy NDC, 4 package rows20231115_e441895a-83b6-1cd5-e053-2995a90aab4b.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82575-03282575-032-01, 82575-032-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ARGAN OIL4V59G5UW9XIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
SQUALANEGW89575KF9IACT
SHEA BUTTERK49155WL9YIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
COCO GLUCOSIDEICS790225BIACT
C14-22 ALCOHOLSB1K89384RJIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYL FERULATE5B8915UELWIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
LEVOMENOL24WE03BX2TIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLUCONOLACTONEWQ29KQ9POTIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM BENZOATEOJ245FE5EUIACT
CHLORPHENESINI670DAL4SZIACT
SORBIC ACIDX045WJ989BIACT
UREA8W8T17847WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
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
Curology the sunscreen broad spectrum SPF 30ZINC OXIDECurology Inc.e441895a-83b6-1cd5-e053-2995a90aab4b2023-11-14WarningsExact identifier
ndc (package): 82575-032-01
ndc (package): 82575-032-00
ndc (product): 82575-032
ndc11 (package): 82575003200
ndc11 (package): 82575003201
spl id: 0a275b15-29c7-521b-e063-6394a90aa742
spl set id: e441895a-83b6-1cd5-e053-2995a90aab4b

Reported adverse events (FAERS/openFDA)#

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