FDA.reportPublic FDA data

MILK TINT SPF 43 TINTED PRIMER SERUM RICH

Product NDC
68577-167
11-digit product format
685770167
Labeler code
68577
Product ID
68577-167_29ac7154-5176-297d-e063-6394a90ac357
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
ZINC OXIDE
Active strength
12.0015 mg/100mg
NDC exclude flag
No
Listing certified through
2026-12-31
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
MILK TINT SPF 43 TINTED PRIMER SERUM RICH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE12.0015 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29ac51a0-07e7-ad7b-e063-6294a90ae777Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-167-00MILK TINT SPF 43 TINTED PRIMER SERUM RICH1 in 1 CARTONLOTION11
68577-167-00MILK TINT SPF 43 TINTED PRIMER SERUM RICH30 mg in 1 BOTTLELOTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-167MILK TINT SPF 43 TINTED PRIMER SERUM RICH (ZINC OXIDE) LOTION [COSMAX USA, CORPORATION]1Current NDC, 2 package rows20241222_29ac51a0-07e7-ad7b-e063-6294a90ae777.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 127 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36af24e2-015a-a9a7-e063-6294a90a2fce2025-12-15Exact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36add3a3-f1ff-3986-e063-6394a90ab7fe2025-12-15Exact identifier
application number: M020
Antioxidant Mineral Sunscreen Plus Primer Lightly TintedZINC OXIDETrue Beauty Brows & Skin Care37dc70ba-a6bb-fe09-e063-6394a90a51292025-12-15Exact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCbcbab676-fbe2-f0cc-e053-2a95a90ad4d22025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14cf2b8-b110-1210-e053-2995a90a01022025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf1504311-4865-5499-e053-2995a90acdcd2025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14d70f1-440b-900d-e053-2995a90a30a02025-12-15WarningsExact identifier
application number: M020
REVERSE Brightening Defense FluidAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATERodan & Fieldsdc230e1e-bfb8-4d7c-bad5-bff77d78220e2025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC MINERAL SPORT SPF50TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCbbf15e58-c160-d599-e053-2a95a90a06962025-12-14WarningsExact identifier
application number: M020
Mineral Sunscreen Stick SPF 50 Fragrance-FreeZINC OXIDECOOLA LLCee8706b0-ad42-403a-be7c-b660f040a2442025-12-14WarningsExact identifier
application number: M020
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-167-00685770167001 BOTTLE in 1 CARTON (68577-167-00) / 30 mg in 1 BOTTLE1 bottle2024-01-01NoNoCurrent