BIOSOLIS Face UVA Sunscreen Broad Spectrum SPF30

Product NDC
61296-004
Requested package NDC
61296-004-00
11-digit product format
612960004
Labeler code
61296
Product ID
61296-004_b5a7b608-d6a9-da2f-e053-2a95a90a8fe0
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Pro Vera SA
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-12-02
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
90 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage61296-00461296-004-00DDiscontinued by firm2026-10-05

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 · 12 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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPBIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZBIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPBIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZBIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0BIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUABIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATBIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATEINACTIVE INGREDIENT9229XJ4V12BIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
POLYGLYCERYL-3 DIISOSTEARATEINACTIVE INGREDIENT46P231IQV8BIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TBIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8BIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VBIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PRO VERA SA]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61296-004-006129600040050 mL in 1 BOTTLE (61296-004-00) 50 ml2013-12-020000-00-00NoNoCurrent