FDA.reportPublic FDA data

SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25

Product NDC
10348-018
Requested package NDC
10348-018-02
11-digit product format
103480018
Labeler code
10348
Product ID
10348-018_f101af62-06db-d7ba-e053-2995a90a5d59
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
SMASHBOX BEAUTY COSMETICS, INC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-02
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
67 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage10348-01810348-018-02IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10348-018-01SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 2540 mL in 1 TUBELIQUID4011
10348-018-01SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 251 in 1 CARTONLIQUID111
10348-018-02SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 257 mL in 1 TUBELIQUID711
10348-018-03SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 2512 mL in 1 TUBELIQUID1211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10348-018SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]11Legacy NDC, 4 package rows20241227_757f5460-8e3d-4d30-bc90-196a1ab3b5fb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10348-018-02103480018027 mL in 1 TUBE (10348-018-02) 7 ml2022-03-020000-00-00YesNoCurrent