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 83 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sun 6 SPF Tan and Care CarrotOCTINOXATEFarmasi US LLC67de9257-70f3-4444-a4a2-a8d7425fcc0e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen SPF30 Broad SpectrumAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLCd9197dce-20a3-4d10-807c-ec84ab9021652026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance BrighteningOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCadf5621b-7cf0-53b3-e053-2a95a90a80582026-01-09WarningsExact identifier
application number: M020
Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15HOMOSALATE, OCTINOXATEFARMASI US LLC1dbd5e83-2248-4751-88d9-b446ccc3c61e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body SunAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLC27fdbd2b-60de-4906-a176-5c5198d9925b2026-01-09WarningsExact identifier
application number: M020
Skin Metal StealthZINC OXIDESkin Metal47f5d7de-5d32-041a-e063-6394a90ab6f92026-01-09WarningsExact identifier
application number: M020
Salt and Blue Body Sunscreen SPF 30ZINC OXIDE 20%Salt + Blue LLC47f764a0-e9ad-ef66-e063-6394a90a8de52026-01-09WarningsExact identifier
application number: M020
City Sunscreen serum Broad Spectrum SPF 30 SupergoopHOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENESupergoop, LLC61766f7b-512d-45b5-b652-e09975a3d3fc2026-01-09WarningsExact identifier
application number: M020
Defense Refresh (Re)Setting Mist SPF 40AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENESupergoop LLCb95ad8e3-978b-b721-e053-2a95a90a1e542026-01-09WarningsExact identifier
application number: M020
Daily Dose Vitamin C and Broad Spectrum SPF 40 SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLCaed0dd03-1695-a5a9-e053-2995a90acfdc2026-01-09WarningsExact identifier
application number: M020
Hand Screen Broad Spectrum Sunscreen SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENESupergoop, LLC972ebab9-3f2f-6716-e053-2a95a90a5c752026-01-09WarningsExact identifier
application number: M020
Glow Oil Broad Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC972c68e7-b137-34c6-e053-2a95a90a77d62026-01-09WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCee045b64-7a95-4378-8183-e6e556f3b1842026-01-09WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC967d0657-18fc-4e4a-b52d-442df43329f12026-01-09WarningsExact identifier
application number: M020
PLAY SPF 30 Lip Shield CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb0b8b850-bdfe-5563-e053-2995a90a51a72026-01-09WarningsExact identifier
application number: M020
Play SPF 30 Lip Shield StrawberryAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb0a49142-53c3-5b7a-e053-2995a90a581d2026-01-09WarningsExact identifier
application number: M020
Glow Stick Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESupergoop, LLC61e543e3-9ace-6440-e053-2991aa0a96472026-01-09WarningsExact identifier
application number: M020
(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35ZINC OXIDESupergoop, LLCaf5c9801-26ce-5c60-e053-2995a90ab4572026-01-09WarningsExact 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