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 310 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b8bc0021-bb4d-45f2-a570-3f2e61edf21d2024-02-16WarningsExact identifier
application number: M020
Meijer SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Meijer075dddd5-46ea-282a-e063-6294a90a28fd2024-02-15WarningsExact identifier
application number: M020
Sheet SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma Inc.bbb5b87c-d641-3ba2-e053-2a95a90a0f702024-02-14WarningsExact identifier
application number: M020
sheer tint SPF 45BROAD SPECTRUMCP Skin Health Group, Inc.b7c5cedd-ff68-74de-e053-2a95a90a37962024-02-14WarningsExact identifier
application number: M020
Weightless Protection SPF 45SUNSCREEN BROAD SPECTRUMCP Skin Health Group, Inc.b6bee26d-bffd-a8ee-e053-2a95a90affc52024-02-14WarningsExact identifier
application number: M020
Active SPF 45BROAD SPECTRUMCP Skin Health Group, Inc.b6c3adfb-d20a-1b67-e053-2a95a90a4b4e2024-02-14WarningsExact identifier
application number: M020
Hydrator Plus SPF 30BROAD SPECTRUMCP Skin Health Group, Inc.b6c0db82-9fba-6216-e053-2a95a90a75602024-02-14WarningsExact identifier
application number: M020
REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/OOCTINOXATE, TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10f7ec01-541b-a15a-e063-6294a90aa9df2024-02-09WarningsExact identifier
application number: M020
SunscreenHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONESafetec of America, Inc.754186c8-3c88-40a0-a4e3-35e3ea9d1b4c2024-02-08WarningsExact identifier
application number: M020
MIAMI BEACH BUM SPF-50 Blocked SunscreenZINC OXIDEMIAMI BEACH BUM2cf40d87-626b-4309-8f13-fd980161c62f2024-02-07WarningsExact identifier
application number: M020
Equate Sunscreen for All Skin Tones SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWAL-MART INC.1062060a-a5c7-1805-e063-6294a90ab8022024-02-02WarningsExact identifier
application number: M020
Equate Kids Sunscreen Broad Spectrum SPF 50 EquateAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWAL-MART INC.10631036-0fa6-b3ee-e063-6294a90af7aa2024-02-02WarningsExact identifier
application number: M020
Death Tan SPF 50 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEDerma Care Research Labs, LLC106ab5e2-e134-b81d-e063-6294a90a5bca2024-02-02WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden HourTITANIUM DIOXIDECOOLA, LLCedfda0f5-0f72-5cc7-e053-2a95a90ae38d2024-02-02WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Summer CrushZINC OXIDECOOLA, LLCedc6754e-dabb-5bff-e053-2a95a90a73902024-02-02WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Skinny DipZINC OXIDECOOLA, LLCee01f936-81a9-a54d-e053-2a95a90a52272024-02-02WarningsExact identifier
application number: M020
toty Solaria MineralTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe9d590d8-e71a-0715-e053-2a95a90a5acf2024-02-01WarningsExact identifier
application number: M020
THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50ZINC OXIDELG H&H Co., Ltd.10d343c8-f0c1-6b90-e063-6294a90a24ba2024-02-01WarningsExact identifier
application number: M020
THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50ZINC OXIDEfmg Co.Ltd10d401af-fd92-d82a-e063-6294a90a9f7f2024-02-01WarningsExact identifier
application number: M020
Elta MD UV AOX EyeZINC OXIDECP Skin Health Group, Inc.0e87b791-6ac1-dd60-e063-6394a90a658c2024-01-31WarningsExact 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