BIOSOLIS Face UVA Sunscreen Broad Spectrum SPF30

Product NDC
61296-004
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61296-004DDiscontinued by firm2026-10-05
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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61296-004-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61296-004-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61296-004-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61296-004-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61296-004-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61296-004-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61296-004-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61296-004-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61296-004-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61296-004-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61296-004-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61296-004-00557ba5c1ecfa…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