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 32 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELAO TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATA,ETHYLHEXYL SALICYATEGuangzhou Haishi Biological Technology Co., Ltd.519d9f52-b704-d6cd-e063-6294a90a6e422026-05-13WarningsExact identifier
application number: M020
Hampton Sun SPF30 MineralZINX OXIDES&C Hampton Sun LLC019b0c1a-f9f3-4756-8b24-35bf4dc4aa222026-05-13WarningsExact identifier
application number: M020
Standard Procedure SPF 50 Sunscreen Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories34f6150d-9627-94a5-e063-6394a90ad4482026-05-13WarningsExact identifier
application number: M020
CeraVe Developed with Dermotologists Ultra Light Moisturizing Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdefa9588-95be-4f5c-86bb-53d6a1df7f5f2026-05-13WarningsExact identifier
application number: M020
MELAO TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATEGuangzhou Haishi Biological Technology Co., Ltd.22982b28-37df-ed81-e063-6394a90a77db2026-05-12WarningsExact identifier
application number: M020
Frase Skin SPF 30 Face Sunscreen Activated Vitamin D TechnologyAVOBENZONE, OCTISALATE, OCTOCRYLENEFrase Skin PTY LTDd904fd23-a3a1-4564-8eec-13a4c96e23f72026-05-12WarningsExact identifier
application number: M020
Hawaii Sol Natural Non-Nano Sunscreen SPF 50ZINC OXIDECaribbean Sol International, LLC24678326-547f-427d-a481-d8c40380e30a2026-05-12WarningsExact identifier
application number: M020
Caribbean Sol Natural Non-Nano Sunscreen SPF 50ZINC OXIDECaribbean Sol International, LLC20aadcf6-16a3-4344-837b-b91ba8753fb02026-05-12WarningsExact identifier
application number: M020
Cancer Council Daily Face Moisturizer SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1b4333b8-5747-c591-e063-6294a90a99242026-05-12WarningsExact identifier
application number: M020
Lather Daily Defense Mineral SPF 45 Facial SunscreenZINC OXIDELather, Inc.50c732a0-b282-d61b-e063-6294a90aa76b2026-05-12WarningsExact identifier
application number: M020
Hampton Sun SPF50 Mineral Face SunscreenHOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%S&C Hampton Sun LLCf1c5310b-c43b-475d-8a50-d55759ad31642026-05-12WarningsExact identifier
application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
application number: M020
Stellar Mineral Glow Guard Sunscreen Broad Spectrum SPF 50ZINC OXIDEStellar Beauty Co.0f7ee8c6-3af2-42a2-b341-3e0da42c7c932026-05-11WarningsExact identifier
application number: M020
Frase Skin SPF 50 Activated Vitamin D Technology CoolAVOBENZONE, OCTISALATE, OCTOCRYLENEFrase Skin PTY LTD0a5cc927-0fd3-4c8f-b847-a274f6eb09fb2026-05-11WarningsExact identifier
application number: M020
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral SunscreenZINC OXIDEMiami Beach Bum3b778530-9af0-48eb-bd91-d9ac99f2983f2026-05-11WarningsExact identifier
application number: M020
Walgreens SPF 60 Melt-in Milk SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalgreens345955ea-f37a-8629-e063-6294a90aa7cc2026-05-11WarningsExact identifier
application number: M020
DERMATONE SPF50 SunscreenAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Dermatone Labs LLC4dc81593-4790-403f-9d49-6569bcd0fea22026-05-11WarningsExact identifier
application number: M020
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
application number: M020
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral SunscreenRADICAL RESCUE SPF 30 MINERAL SUNSCREENProTransit, Inc.38e0139c-bb87-55ba-e063-6294a90a82ee2026-05-11WarningsExact 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