FDA.reportPublic FDA data

Les Coja Organic SPF 30

Product NDC
60717-430
11-digit product format
607170430
Labeler code
60717
Product ID
60717-430_485d31e4-a2aa-8165-e063-6294a90a14fc
Type
HUMAN OTC DRUG
Nonproprietary name
Ethylhexyl Salicylate, Homosalate, Butyl Methoxydibenzoylmethane
Dosage form
LOTION
Route
TOPICAL
Labeler
RNA PHARMA, LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-14
Substance
HOMOSALATE; ETHYLHEXYL SALICYLATE; BUTYL METHOXYDIBENZOYLMETHANE
Active strength
.05; .05; .03 g/g; g/g; g/g
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
Les Coja Organic SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE.05 g/g
ETHYLHEXYL SALICYLATE.05 g/g
BUTYL METHOXYDIBENZOYLMETHANE.03 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
485d31e4-a2a9-8165-e063-6294a90a14fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60717-430-04Les Coja Organic SPF 30113 g in 1 TUBELOTION1131

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 4 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Best Choice Earwax Removal DropsCARBAMIDE PEROXIDEValu Merchandisers Company3ae6255f-f494-412b-af76-3579de08ed232025-02-28WarningsExact identifier
application number: M014
Equaline Earwax Removal DropsCARBAMIDE PEROXIDEUnited Natural Foodsd853567a-ce8d-40a8-be1e-27176802ff642025-02-28WarningsExact identifier
application number: M014
Family Wellness Earwax Removal Earwax and BulbCARBAMIDE PEROXIDEFamily Dollar Services Inc26ebf208-4710-4af2-aa2d-b2040b85cf852025-02-28WarningsExact identifier
application number: M014
FOSTER AND THRIVE EARWAX REMOVAL DROPSCARBAMIDE PEROXIDEA-S Medication Solutions0a571ae8-237b-447d-b697-02b30692b6b12025-02-24WarningsExact identifier
application number: M014
Pain Be GoneMENTHOLBack to Earth Inc.f49e718b-ef89-b648-e053-2a95a90a96c82025-01-29WarningsExact identifier
application number: M014
DEBROXCARBAMIDE PEROXIDEMedtech Products Inc.43649ba3-75e0-4dcf-9172-23767dbaeda62025-01-27WarningsExact identifier
application number: M014
HylaTearsEYE DROPSHyalogic LLC2b5fc4c4-843c-8d3d-e063-6394a90a5a1b2025-01-10WarningsExact identifier
application number: M014
BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZINGETHYL ALCOHOLRobanda International, Inc.ebec43d4-4676-40f9-b989-5381f4a737c82025-01-08WarningsExact identifier
application number: M014
Dr. TalbotsETHYL ALCOHOLTalbots Pharmaceuticals Family Products, LLC.a6a94205-a9ff-7709-e053-2995a90a066b2025-01-08WarningsExact identifier
application number: M014
Foster and Thrive Earwax Removal Kit Ear wax dropsCARBAMIDE PEROXIDEMckesson Corp. Via Strategic Sourcing Servicesc9bd4c1f-b3b8-4bdc-b529-3a98b657e6282024-12-31WarningsExact identifier
application number: M014
Foster and Thrive Earwax Removal DropsCARBAMIDE PEROXIDEMckesson Corp. Via Strategic Sourcing Services6180835c-d7a7-4bf7-95cb-0fd3c81402532024-12-31WarningsExact identifier
application number: M014
OIDO SANAISOPROPYL ALCOHOLProMex LLC71e84695-49e8-459f-ac5e-118b5235fe062024-12-18WarningsExact identifier
application number: M014
ERO Ear Wax Removal KitCARBAMIDE PEROXIDE 6.5%Randob Labsfbf8a6f2-531d-5047-e053-6294a90aaa012024-12-15WarningsExact identifier
application number: M014
Harris Teeter Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Harris Teeter LLCdda4c4bf-425e-4fff-e053-2a95a90a51bc2024-12-15WarningsExact identifier
application number: M014
Isopropyl AlcoholISOPROPYL ALCOHOLMazza Healthcare, LLCee83ba9f-ac65-48b7-9f84-5be6fec9a9092024-11-21WarningsExact identifier
application number: M014
Ear Wax Removal Drops Up and UpCARBAMIDE PEROXIDE - 6.5%Target Corporation829ece50-1f26-4f69-b000-010a34d4cd542024-11-21WarningsExact identifier
application number: M014
Walgreens Ear Wax RemoverCARBAMIDE PEROXIDE 6.5%Walgreens Companyd3b7362b-2826-4b86-bfa3-ef302dc791432024-11-20WarningsExact identifier
application number: M014
CLEARCANAL EAR WAX SOFTERNER DROPSCARBAMIDE PEROXIDEA-S Medication Solutionsac3d57a4-08d5-45f1-be84-f68eef9d13982024-11-04WarningsExact identifier
application number: M014
Caladryl ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEBausch Health US, LLCfca6f08b-7fa0-4ae6-bce3-61f3bcae43322024-10-17WarningsExact identifier
application number: M014
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
application number: M014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60717-430-0460717043004113 g in 1 TUBE (60717-430-04) 113 g2026-01-14NoNoCurrent