FDA.reportPublic FDA data

Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50

Manufacturer
Cosmocos Co., Ltd
Effective date
2025-10-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:39:27

Label at a glance#

ProductDanahan Moisture Daily Sunscreen Broad Spectrum SPF 50
Active ingredientOCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATE, ENSULIZOLE
Label structure14 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 skin aging caused by the sun

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure ​Reapply: ​​Immediately after towel drying ​At least every 2 hours Use a water resistant sunscreen if swimming or sweating 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 measur...

Storage and handling

Protect the product in this container from excessive heat and direct sun May stain some fabrics or surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Ensulizole 3%
Homosalate 10%
Octisalate 3%
Octocrylene 10%
Zinc Oxide 3.02%

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 skin aging caused by the sun

WARNINGS

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

  • Do not use​ on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this product keep out of the eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply generously and evenly 15 minutes before sun exposure
  • ​Reapply:
  • ​​Immediately after towel drying
  • ​At least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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 age: Ask a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun
  • May stain some fabrics or surfaces.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Propanediol, Acrylates Copolymer, 1,2-Hexanediol, Niacinamide, Polyglyceryl-3 Distearate, Tromethamine, Pentylene Glycol, Caprylyl Methicone, Poly C10-30 Alkyl Acrylate, Glyceryl Stearate, Potassium Cetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Alcohol, Polyurethane-15, Glyceryl Stearate Citrate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Caprylyl Glycol, Polyacrylate Crosspolymer-6, Sodium Polyacryloyldimethyl Taurate, Hydroxypropyl Methylcellulose Stearoxy Ether, Glycerin, Triethoxycaprylylsilane, Ethylhexylglycerin, Adenosine, Butylene Glycol, Hydrogenated Lecithin, Polyglyceryl-10 Oleate, Glycine Soja (Soybean) Sterols, Polyglyceryl-10 Isostearate, Beta-Glucan, Caprylic/Capric Triglyceride, Tocopherol, Panax Ginseng Root Extract, Panax Ginseng Seed Oil, Vinegar, Sorbitan Isostearate

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

CS Toll-Free Number
1-888-264-1294

Distributed by

COSMOCOS Co., ltd.
404, Aenggogae-ro,
Namdong-gu, Incheon,
Republic of Korea (21698)
www.cosmocos.com
MADE IN KOREA

PRINCIPAL DISPLAY PANEL: 50 mL / 1.7 FL OZ Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Moisture Daily Sunscreen

SPF 50

BROAD SPECTRUM SPF 50

Net Wt. 50 mL / 1.7 FL OZ

Danahan

danahan_moisture_daily_sunscreen_spf50_50mL_ocdanahan_moisture_daily_sunscreen_spf50_50mL_oc

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138808033030689GTIN-13: 8808033030689
EAN-13: 8808033030689
GTIN storage (14 digits): 08808033030689		danahan_moisture_daily_sunscreen_spf50_50mL_oc.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83305-001-50Danahan Moisture Daily Sunscreen Broad Spectrum SPF 5050 mL in 1 TUBECREAM501
83305-001-50Danahan Moisture Daily Sunscreen Broad Spectrum SPF 501 in 1 BOXCREAM11

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83305-00183305-001-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB
ENSULIZOLE9YQ9DI1W42ACTIB
WATER059QF0KO0RIACT

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
Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECosmocos Co., Ltd41129799-85ed-2de2-e063-6394a90ab40c2025-10-17WarningsExact identifier
ndc (package): 83305-001-50
ndc (product): 83305-001
ndc11 (package): 83305000150
spl id: 41129ed1-a0d2-2de4-e063-6394a90a3f25
spl set id: 41129799-85ed-2de2-e063-6394a90ab40c

Reported adverse events (FAERS/openFDA)#

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