Mineral Sunscreen

Product NDC
49358-553
Requested package NDC
49358-553-01
11-digit product format
493580553
Labeler code
49358
Product ID
49358-553_039a9fac-5a9d-4219-b101-6c8dba730da4
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
MDSolarSciences
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
1 g/12g; g/12g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49358-55349358-553-01IInactivated by FDA2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49358-553-012023-01-30C16284748780-1f386c649-d73c-0266-e053-dadaa90a7c1aMineral Sunscreen Stick Broad Spectrum SPF 40 Sunscreen UVA-UVB Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-553-01Mineral Sunscreen Broad Spectrum SPF 40 Sunscreen UVA-UVB Sunscreen1 in 1 CARTONSTICK13
49358-553-01Mineral Sunscreen Broad Spectrum SPF 40 Sunscreen UVA-UVB Sunscreen17 g in 1 TUBESTICK173

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
BEHENYL OLIVATEINACTIVE INGREDIENTNGS1GGK4GWMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
BENZYLIDENE DIMETHOXYDIMETHYLINDANONEINACTIVE INGREDIENT75HIF3C97LMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
BUTYLOCTYL OLEATEINACTIVE INGREDIENT2830Y2FNR6MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0XMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1OMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
GLYCERYL ISOSTEARATEINACTIVE INGREDIENTHYE7O27HAOMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
NEOPENTYL GLYCOL DIHEPTANOATEINACTIVE INGREDIENT5LKW3C543XMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VMINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-553MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]3Legacy NDC, 2 package rows20181019_bce5be25-a7f8-4cea-a6a9-c2e9ac5dad6a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49358-553-01493580553011 TUBE in 1 CARTON (49358-553-01) > 17 g in 1 TUBE1 tube2016-02-010000-00-00NoNoCurrent