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 321 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC5f5fb9f5-00be-420a-b19a-b753c45f9a882023-12-12WarningsExact identifier
application number: M020
Boscia Self-Defense Vital Antioxidant Moisture Broad Spectrum SPF 30AVOBENZONE, OCTINOXATEBoscia LLC7d948951-598a-4a38-94a2-d357ee7f4d1e2023-12-12WarningsExact identifier
application number: M020
Restorative Day Moisture SPF 15OCTINOXATE, AVOBENZONEBoscia LLC01f17133-7f29-4f8e-a52c-c4466e4abefc2023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 03TITANIUM DIOXIDE3LAB, Inc.8a42a9d8-b9c6-45fb-8264-15f36e2765f02023-12-12WarningsExact identifier
application number: M020
3LAB Hydra Day SPF 20 Broad Spectrum Water-Based SunscreenOCTINOXATE, OCTISALATE, AVOBENZONE3LAB, Incd539b851-c4b2-40a2-9562-e3a95a86b7442023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT Lite Sunscreen SPF 30 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDE3LAB, Inc3052af3f-8923-47bc-be6e-17396275363a2023-12-12WarningsExact identifier
application number: M020
Isa SunGuard SPF 30ZINC OXIDE, TITANIUM DIOXIDEIsagenix International, LLCabe1e345-6ea2-43b3-8613-b5b5e04c87b72023-12-12WarningsExact identifier
application number: M020
Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC5169b10e-5a8d-479a-a6a8-1e7a13cb70c42023-12-12WarningsExact identifier
application number: M020
Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20TITANIUM DIOXIDEBoscia LLCf76166f1-e987-4eaf-8192-14dc08c481f72023-12-12WarningsExact identifier
application number: M020
Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBoscia LLC2a6b507f-0967-46e1-8360-0003772f1bdb2023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Oily SkinOCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporated97bd2033-2cf0-4e5d-81e2-c453a1e3a65e2023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 01TITANIUM DIOXIDE3LAB, Inc.703dc828-24b4-4f04-9f2c-4a2edfdf46322023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 02TITANIUM DIOXIDE3LAB, Inc.7c6c7062-91f7-4304-98c3-f77967a2d3292023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Dry SkinOCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporated8a75dde9-8dcb-4f4a-b9df-88338bd2a4402023-12-12WarningsExact identifier
application number: M020
Everyday Facial Moisturizer And Sunscreen SPF 20ZINC OXIDE714 Essentials LTD3a29018b-8103-4983-b0c5-5f340775a05d2023-12-12WarningsExact identifier
application number: M020
Likewise Hand Moisturizer - Sun Protectant SPF 50OCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporateda54f0854-c55e-4a46-9084-16cb1be0f6812023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 01TITANIUM DIOXIDE3LAB, Incbd39d2fb-8326-4e19-b634-7a7308313d8a2023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 03TITANIUM DIOXIDE3LAB, Inc19884289-edb2-4d18-bd62-873533b94a102023-12-12WarningsExact identifier
application number: M020
Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.92dc1a86-590e-4144-9d30-172645e631402023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 02TITANIUM DIOXIDE3LAB, Incbf4419b9-408d-469a-aa15-bbf419632f022023-12-12WarningsExact 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