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
BUTYL METHOXYDIBENZOYLMETHANE; ETHYLHEXYL SALICYLATE; HOMOSALATE
Active strength
.03; .05; .05 g/g; g/g; g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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.03 g/g
ETHYLHEXYL SALICYLATE.05 g/g
BUTYL METHOXYDIBENZOYLMETHANE.05 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 1 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC54dc3642-0b7a-07d8-e063-6294a90ad5562026-07-22WarningsExact identifier
application number: M014
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC55057e1b-b11e-51b9-e063-6394a90a9fca2026-07-22WarningsExact identifier
application number: M014
Macks Dry n ClearEAR DRYING AIDMcKeon Products Inc1ea1da54-2412-c25c-e063-6294a90aa2642026-06-26WarningsExact identifier
application number: M014
Equate Swimmers Instant Ear DryEQUATE SWIMMERS INSTANT EAR DRYWalmart Stores, Inc76b58a7a-48cf-866c-e053-2a91aa0a7e632026-06-26WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.c68b40d9-c1d4-4425-8063-50c00299e7182026-06-10WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.b2a641da-e070-4223-b836-5ca9ffb89f3f2026-06-10WarningsExact identifier
application number: M014
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-06-03WarningsExact identifier
application number: M014
Audiologists Choice Earwax Removal SystemCARBAMIDE PEROXIDEOaktree Products Inc.c9ad507b-341c-474f-aaa2-3c3a97a30dd82026-05-29WarningsExact identifier
application number: M014
CVS Health Earwax Removal KitCARBAMIDE PEROXIDECVS Pharmacy, Inc.f842534c-46dd-42c7-8386-9a03ce16da862026-05-29WarningsExact identifier
application number: M014
Lucid Hearing Earwax Removal Kit and BulbCARBAMIDE PEROXIDEHearing Lab Technology LLC5e09f566-397f-44d6-8ba2-90987765c7372026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEAmerisource Bergen89eac1b0-c700-45b5-8478-da53ace72e162026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax RemovalCARBAMIDE PEROXIDEAmerisource Bergend503b10f-85cd-4bb8-9dec-82d651d525fa2026-05-29WarningsExact identifier
application number: M014
Meijer Earwax Removal KitCARBAMIDE PEROXIDEMeijer Distribution Inc.a5f7bd55-55c3-4b0e-a16c-33bbea40536a2026-05-29WarningsExact identifier
application number: M014
Quality Choice Earwax Removal DropsCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.d8fd8102-114f-415d-9083-f98a63f9d1b32026-05-29WarningsExact identifier
application number: M014
Menthol Pain Relieving GelPAIN RELIEVING GELNeilMed Pharmaceuticals Inc513a206c-bbf6-3e51-e063-6294a90adf7a2026-05-07WarningsExact identifier
application number: M014
ear dropsCARBAMIDE PEROXIDE 6.5%Bionpharma Inc.e8bcf92c-ad32-49d5-e053-2995a90ae0c62026-04-27WarningsExact identifier
application number: M014
Freskaro Earwax Removal AidCARBAMIDE PEROXIDE 6.50% KITPharma Nobis, LLC4f5967ee-bc05-341c-e063-6394a90a35c62026-04-15WarningsExact identifier
application number: M014
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.9a4198d2-cbea-466a-a252-d5c63d9ea0c12026-04-09WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.52f733a7-1301-4078-9267-5ce95b006ccc2026-04-09WarningsExact identifier
application number: M014
Walgreens Swimmers EarISOPROPYL ALCOHOLWalgreens Co3fb65a5c-c47f-ef2b-e063-6394a90af21a2026-04-01WarningsExact 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