FDA.reportPublic FDA data

COSRX

Product NDC
70319-240
11-digit product format
703190240
Labeler code
70319
Product ID
70319-240_4840f608-944b-3e3d-e063-6394a90a1d9d
Type
HUMAN OTC DRUG
Nonproprietary name
Vitamin E Vitalizing Sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
COSRX inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-19
Substance
OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength
2.25; 1.25; 4.5; 4.5 mg/50mL; mg/50mL; mg/50mL; mg/50mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
COSRX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE2.25 mg/50mL
AVOBENZONE1.25 mg/50mL
OCTOCRYLENE4.5 mg/50mL
HOMOSALATE4.5 mg/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4840f608-944a-3e3d-e063-6394a90a1d9dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70319-240-01COSRX50 mL in 1 TUBELOTION501
70319-240-01COSRX1 in 1 CARTONLOTION11

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 127 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA CLASSIC SUNSCREEN FRAGRANCE FREEAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCcfc21b1a-4a26-1573-e053-2995a90a2d502025-12-14WarningsExact identifier
application number: M020
Kopari Sunglaze Sheer Body Mist Sunscreen SPF42AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKopari Beauty7c96b799-e24d-473f-8f0a-3fad83d5ed482025-12-14WarningsExact identifier
application number: M020
WOODSLEEP Sunscreen BalmTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.45cfc7ed-34a6-1f45-e063-6394a90a902b2025-12-13WarningsExact identifier
application number: M020
Universkin by Alma Daily Mineral Serum Broad Spectrum SPF50ZINC OXIDE 24%UNIVERSKIN45d242de-cbd8-e7ea-e063-6394a90aaebf2025-12-13WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE SPF 50ALAINA HEALTHCARE PRIVATE LIMITEDb7847d4f-2517-4b58-8e31-676c9d6e484d2025-12-12WarningsExact identifier
application number: M020
Lip ProtectingTITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544b8f2-2651-4c01-e063-6394a90ae53d2025-12-12Exact identifier
application number: M020
Tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544faa1-ebdf-5dbd-e063-6394a90a76312025-12-12Exact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDESOLUTIONS SKIN CARE LLC40323dfa-29e4-1464-e063-6294a90aa65c2025-12-12WarningsExact identifier
application number: M020
Zinc 20Percent SPF 40ZINC OXIDEJOHANNA'S SKIN CARE3545ed3e-b42f-d29d-e063-6394a90a8efe2025-12-12Exact identifier
application number: M020
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC40332cf3-e4e5-0c00-e063-6394a90a683d2025-12-12WarningsExact identifier
application number: M020
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032913b-4bc3-6920-e063-6294a90a6e2d2025-12-12WarningsExact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032f0b0-c083-d227-e063-6394a90a30682025-12-12WarningsExact identifier
application number: M020
Everyday Mineral SunscreenZINC OXIDEMYRENE DULAY-MARTINEZ396d952b-22ff-567f-e063-6394a90a8c682025-12-12Exact identifier
application number: M020
Everyday Mineral SunscreenZINC OXIDEMYRENE DULAY-MARTINEZ396dfc9c-b6c0-5892-e063-6394a90a110c2025-12-12Exact identifier
application number: M020
KawaKids KawaSun - Premium Mineral Sunscreen SPF 50ZINC OXIDELCA COSMETICS LLC1f41f64b-d707-08e2-e063-6294a90aa9242025-12-12WarningsExact identifier
application number: M020
KawaKids KawaSun - Premium On-The-Go Mineral Sunscreen SPF 50ZINC OXIDELCA COSMETICS LLC1f4341f7-b499-3b73-e063-6394a90a75b82025-12-12WarningsExact identifier
application number: M020
Advanced Mineral SunscreenZINC OXIDECharisma Skin351f7f72-c426-e42f-e063-6294a90a4b3a2025-12-12Exact identifier
application number: M020
Advanced Mineral SunscreenZINC OXIDECharisma Skin351f06f3-9deb-4c1a-e063-6394a90ad7662025-12-12Exact identifier
application number: M020
Daily Mineral ProtectionZINC OXIDECharisma Skin352d72f6-06b9-6fdc-e063-6294a90ab4482025-12-12Exact identifier
application number: M020
Daily Mineral ProtectionZINC OXIDECharisma Skin352dc69b-86d0-aa15-e063-6294a90a5e4c2025-12-12Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70319-240-01703190240011 TUBE in 1 CARTON (70319-240-01) / 50 mL in 1 TUBE1 tube2026-01-19NoNoCurrent