MedPath

Curology Daily Moisturizing Sunscreen SPF 30

Curology Daily Moisturizing Lotion Sunscreen SPF 30

Approved
Approval ID

ee59d52e-5dc6-4fb4-96d8-0bda40e23009

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 8, 2025

Manufacturers
FDA

Curology

DUNS: 104103284

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82575-036
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 8, 2025
FDA Product Classification

INGREDIENTS (22)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYL TRIMETHICONEInactive
Code: S73ZQI0GXM
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERInactive
Code: W59H9296ZG
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
GLYCERYL MONOOLEATE CITRATEInactive
Code: NLE5KIG74K
Classification: IACT
POLYACRYLATE-13Inactive
Code: FS2D4T67EA
Classification: IACT
CAPRYLHYDROXAMIC ACIDInactive
Code: UPY805K99W
Classification: IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEInactive
Code: YA22H34H9Q
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
ZINC PIDOLATEInactive
Code: C32PQ86DH4
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
AVOBENZONEActive
Quantity: 15 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 50 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 40 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 60 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/8/2025

Package Labeling:

Outer Package03Inner Package03

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/8/2025

Uses

Helps prevent sunburn

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/8/2025

Other information

  • store at 20°-25° (68°-77°F)
  • protect the product in this container from excessive heat and direct sun

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/8/2025

Active ingredients

Avobenzone 1.5%
Homosalate 5%
Octisalate 4%
Octocrylene 6%

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 8/8/2025

Warnings

For external use only.

Keep out of reach of children.

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

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/8/2025

Directions

  • apply generously 15 minutes before sun exposure
  • reapply 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 value 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 of of age: Ask a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/8/2025

Inactive ingredients

Water, Methyl Trimethicone, Propanediol, Silica, Glycerin, Butyloctyl Salicylate, Ammonium Acryloyldimethyltaurate/VP Copolymer, 1,2-Hexanediol, Glyceryl Oleate Citrate, Polyacrylate-13, Polyisobutene, Caprylhydroxamic Acid, Trisodium Ethylenediamine Disuccinate, Niacinamide, Panthenol, Zinc PCA, Sodium Citrate, Tocopheryl Acetate, Polysorbate 20

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