FDA.reportPublic FDA data

YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM

Product NDC
59735-178
11-digit product format
597350178
Labeler code
59735
Product ID
59735-178_4faf81e2-86ec-b2ad-e063-6394a90a9de4
Type
HUMAN OTC DRUG
Nonproprietary name
YOUR NAME MINERAL SHEER TINT
Dosage form
CREAM
Route
TOPICAL
Labeler
PML NYC, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-02-01
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
5; 5 g/30mL; g/30mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59735-178IInactivated by FDA2026-10-21
excluded packagepackage59735-17859735-178-01IInactivated by FDA2026-10-21
excluded packagepackage59735-17859735-178-04IInactivated by FDA2026-10-21
excluded packagepackage59735-17859735-178-06IInactivated by FDA2026-10-21
excluded packagepackage59735-17859735-178-08IInactivated by FDA2026-10-21
excluded packagepackage59735-17859735-178-10IInactivated by FDA2026-10-21
excluded packagepackage59735-17859735-178-12IInactivated by FDA2026-10-21
excluded packagepackage59735-17859735-178-14IInactivated by FDA2026-10-21
excluded packagepackage59735-17859735-178-16IInactivated by FDA2026-10-21

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
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE5 g/30mL
TITANIUM DIOXIDE5 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
316d1515-6092-a7d6-e063-6394a90ab8b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
59735-178-01YOUR NAME MINERAL SHEER TINT BROAD SPECTRUM SPF 20-MEDIUM
59735-178-04YOUR NAME MINERAL SHEER TINT BROAD SPECTRUM SPF 20-MEDIUM
59735-178-06YOUR NAME MINERAL SHEER TINT BROAD SPECTRUM SPF 20-MEDIUM
59735-178-08YOUR NAME MINERAL SHEER TINT BROAD SPECTRUM SPF 20-MEDIUM
59735-178-10YOUR NAME MINERAL SHEER TINT BROAD SPECTRUM SPF 20-MEDIUM
59735-178-12YOUR NAME MINERAL SHEER TINT BROAD SPECTRUM SPF 20-MEDIUM
59735-178-14YOUR NAME MINERAL SHEER TINT BROAD SPECTRUM SPF 20-MEDIUM
59735-178-16YOUR NAME MINERAL SHEER TINT BROAD SPECTRUM SPF 20-MEDIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-178-17YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM30 mL in 1 TUBECREAM307
59735-178-18YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM1 in 1 CARTONCREAM17
59735-178-01YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM30 mL in 1 TUBECREAM305
59735-178-01YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM1 in 1 CARTONCREAM15
59735-178-03YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM30 mL in 1 TUBECREAM305
59735-178-04YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM1 in 1 CARTONCREAM15
59735-178-05YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM30 mL in 1 TUBECREAM305
59735-178-06YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM1 in 1 CARTONCREAM15
59735-178-07YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM30 mL in 1 TUBECREAM305
59735-178-08YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM1 in 1 CARTONCREAM15
59735-178-09YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM30 mL in 1 TUBECREAM305
59735-178-10YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM1 in 1 CARTONCREAM15
59735-178-11YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM30 mL in 1 TUBECREAM305
59735-178-12YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM1 in 1 CARTONCREAM15
59735-178-13YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM30 mL in 1 TUBECREAM305
59735-178-14YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM1 in 1 CARTONCREAM15
59735-178-15YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM30 mL in 1 TUBECREAM305
59735-178-16YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-178YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM (YOUR NAME MINERAL SHEER TINT) CREAM [MANA PRODUCT, INC]6Current NDC, 2 package rows20250331_316d1515-6092-a7d6-e063-6394a90ab8b2.zip
59735-178YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM (YOUR NAME MINERAL SHEER TINT) CREAM [MANA PRODUCT, INC]5Current NDC, 16 package rows20240805_0e2466fb-cb13-5181-e063-6394a90a8883.zip

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 95 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Oil-Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccda04484-ba84-2276-e053-2a95a90a41c82025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd474fea9-65a7-672b-e053-2a95a90ab9892025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 40AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incd4d9ad73-6394-2391-e053-2a95a90a2df62025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incdf498e82-e1c9-51eb-e053-2a95a90a49b62025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd3984138-763b-1002-e053-2995a90acefc2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd8b0d5ad-a82c-5304-e053-2a95a90afa632025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incd8d80a15-8282-a18e-e053-2a95a90a2c6c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd915cb28-2813-5a38-e053-2a95a90a45c62025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59735-178-015973501780130 mL in 1 TUBE30 mlHistorical
59735-178-035973501780330 mL in 1 TUBE30 mlHistorical
59735-178-04597350178041 in 1 CARTONHistorical
59735-178-055973501780530 mL in 1 TUBE30 mlHistorical
59735-178-06597350178061 in 1 CARTONHistorical
59735-178-075973501780730 mL in 1 TUBE30 mlHistorical
59735-178-08597350178081 in 1 CARTONHistorical
59735-178-095973501780930 mL in 1 TUBE30 mlHistorical
59735-178-10597350178101 in 1 CARTONHistorical
59735-178-115973501781130 mL in 1 TUBE30 mlHistorical
59735-178-12597350178121 in 1 CARTONHistorical
59735-178-135973501781330 mL in 1 TUBE30 mlHistorical
59735-178-14597350178141 in 1 CARTONHistorical
59735-178-155973501781530 mL in 1 TUBE30 mlHistorical
59735-178-16597350178161 in 1 CARTONHistorical
59735-178-175973501781730 mL in 1 TUBE30 mlHistorical
59735-178-18597350178181 TUBE in 1 CARTON (59735-178-18) / 30 mL in 1 TUBE (59735-178-17) 1 tube2011-02-01NoNoCurrent