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 101 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mine Line Coconut Sunscreen SPF 50ZINC OXIDESpa de Soleil4642b1cc-43b1-6997-e063-6394a90ac7642025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 30 Broad Spectrum SunscreenSPF 30 BROAD SPECTRUM SUNSCREENSnugZ/USA, LLC69ac1218-76e6-04ff-e053-2a91aa0a40802025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Sunscreen SprySPF 50 SUNSCREEN SPRAYSnugZ USA9390ea21-9f9f-14e2-e053-2a95a90ac5772025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 15 Flavored Beeswax Lip BalmSPF 15 FLAVORED BEESWAX LIP BALMSnugZ/USA, LLC69bdfaaf-d49e-bf31-e053-2a91aa0affd32025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Broad Spectrum SunscreenSPF 50 BROAD SPECTRUM SUNSCREENSnugZ/USA, LLCb7a3eed5-c8ca-ffda-e053-2a95a90a73bb2025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 15 Beeswax Lip BalmSPF 15 BEESWAX LIP BALMSnugZ/USA, LLC68816d3a-dbe9-7ce3-e053-2a91aa0a395e2025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 30 Soy Lip BalmSPF 30 SOY LIP BALMSnugZ/USA, LLC687ff49d-2d0e-2534-e053-2991aa0a28642025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Sunscreen StickSPF 50 SUNSTICKSnugZ/USA, LLC6e1179cf-5bfb-1156-e053-2991aa0a5b462025-12-29WarningsExact identifier
application number: M020
OUHOE Face Body SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d36f60-2a5d-816e-e063-6294a90a2ddc2025-12-26WarningsExact identifier
application number: M020
OUHOE Bean SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d3b11f-93d9-0e38-e063-6294a90a41c32025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe922d89c-4232-77d8-e053-2995a90a85e52025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe9231470-9292-0e70-e053-2a95a90a767a2025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe92288bb-739a-2f73-e053-2995a90ac01f2025-12-26WarningsExact identifier
application number: M020
StriVectin-SH NIA-114 UVA UVB Shields SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONEStriVectin Operating Company Inc.232cbde4-d8ea-4831-9b44-c2e93203260a2025-12-26WarningsExact identifier
application number: M020
CardonAVOBENZONE, HOMOSALATE, OCTYL SALICYLATECardon, Inc72ee2c06-242e-29a2-e053-2991aa0ad8dc2025-12-26WarningsExact identifier
application number: M020
OUHOE Water-Permeable SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46e63e1e-7851-ca26-e063-6394a90a9b532025-12-26WarningsExact identifier
application number: M020
OUHOE Sun MilkTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46e678dd-13c5-b317-e063-6294a90aa9892025-12-26WarningsExact identifier
application number: M020
Dermatone Sport SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Dermatone Labs LLC0e60e5bb-b941-4114-933a-29480bff59602025-12-24WarningsExact identifier
application number: M020
Intelligent Elixirs Tinted Broad Spectrum SPF 30 - NaturalAVOBENZONE, OCTISALATE, OCTINOXATEIntelligent Elixirs, LLC287a61d8-0056-6211-e063-6394a90aa3da2025-12-24WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen for the faceHOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b5997-d229-60ee-e063-6394a90a68db2025-12-23WarningsExact 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