FDA.reportPublic FDA data

MILKY MINERAL SUN SERUM

Product NDC
69949-400
11-digit product format
699490400
Labeler code
69949
Product ID
69949-400_351e1b77-13d6-4b8e-ae2f-547cd8f22428
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Synchronicity Spa, Inc. DBA Suntegrity
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
72; 95 mg/mL; mg/mL
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
MILKY MINERAL SUN SERUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE72 mg/mL
ZINC OXIDE95 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
53834c89-b3b4-4e21-b9f6-19f95e78ba83Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69949-400-01MILKY MINERAL SUN SERUM100 mL in 1 BOTTLE, PUMPLOTION1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69949-400MILKY MINERAL SUN SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]2Current NDC, Legacy NDC, 1 package rows20241124_53834c89-b3b4-4e21-b9f6-19f95e78ba83.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 163 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunsolve MD Volumize and Condition LipZINC OXIDESunsolve MD396b7462-d597-4bf7-e063-6394a90ab58d2025-11-14WarningsExact identifier
application number: M020
Sunsovle MD Volumize and RestoreZINC OXIDESunsolve MD Inc26f3cdda-b990-15cb-e063-6394a90ade292025-11-14WarningsExact identifier
application number: M020
Naturium Dew-Glow Moisturizer SPF 50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc0a5b80fb-caeb-eb56-e063-6294a90a238b2025-11-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d82f310-f87a-f76d-e063-6294a90af2512025-11-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-deepHOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d865e74-1baf-6a44-e063-6394a90a37ac2025-11-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-mediumHOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d8616a8-2eab-c85c-e063-6294a90a39842025-11-14WarningsExact identifier
application number: M020
Naturium UV Reflect Antioxidant SPF 50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc0a5c6fc8-6cdc-0ae5-e063-6394a90ae01c2025-11-14WarningsExact identifier
application number: M020
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc372894af-bed7-474f-95d4-69a8c3f215ef2025-11-14WarningsExact identifier
application number: M020
HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEONEAND CO., LTD.2dc41560-f4a7-5f0b-e063-6294a90a06302025-11-13WarningsExact identifier
application number: M020
Covey Sun and Done Daily MoisturizingZINC OXIDECovey Skinfbcf8204-0673-99aa-e053-6294a90ac26e2025-11-13WarningsExact identifier
application number: M020
SOL Science The FiftyZINC OXIDEBeauty Pie01548858-8b0e-494a-e063-6294a90a8e992025-11-13WarningsExact identifier
application number: M020
Balmere Mineral Sunscreen Moisturizer PrimerZINC OXIDEBalmere00d813e0-eb97-a6ba-e063-6394a90aa5252025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION FRESH PEACH DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever437eb2a8-428c-8339-e063-6394a90a74b22025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION ORIGINAL CLEAN DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever437f4db5-552f-1550-e063-6394a90aaedb2025-11-13WarningsExact identifier
application number: M020
Depology Essential Mineral UV CareZINC OXIDEDepology Holdings LLC1d48cdee-be67-14c0-e063-6294a90a74222025-11-13WarningsExact identifier
application number: M020
Hanalei Face MoisturizingZINC OXIDEHanalei Beauty Company LLC1f7c1a68-5aea-0deb-e063-6394a90a3a432025-11-13WarningsExact identifier
application number: M020
Glo SkinTITANIUM DIOXIDE, ZINC OXIDEGlo Skin Beautyf4bed574-68c1-0d2c-e053-2a95a90a15ff2025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION SOFT SENSITIVE DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever4380036a-7698-03e7-e063-6294a90a73012025-11-13WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL AIR FIT SUNSCREENSUNSCREENTPERENNEBELLfe2148db-9020-9343-e053-6294a90adf702025-11-13WarningsExact identifier
application number: M020
skin MDOCTINOXATE, OCTISALATE, HOMOSALATE21st Century Formulationse809e1d3-0a6d-730d-e053-2a95a90aedb92025-11-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69949-400-0169949040001100 mL in 1 BOTTLE, PUMP (69949-400-01) 100 ml2022-04-010000-00-00NoNoCurrent