FDA.reportPublic FDA data

BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen

Product NDC
0316-0300
11-digit product format
003160300
Labeler code
0316
Product ID
0316-0300_45879704-3fc3-1616-e063-6394a90afe59
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-25
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
66.6; 99.9 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
BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE66.6 mg/mL
TITANIUM DIOXIDE99.9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ece7565b-f3e5-3386-e053-2a95a90a5802Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0300-50BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen1 in 1 CARTONLOTION14
0316-0300-50BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen50 mL in 1 TUBELOTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0300BIOJUVE MICROBIOME-SAFE SHEER FINISH SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20241103_ece7565b-f3e5-3386-e053-2a95a90a5802.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 100 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium TanHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47387d5f-e77b-5633-e063-6294a90a55842025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - TanHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4738be66-0fe8-148e-e063-6394a90a1b022025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan DeepHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4738eed1-9f72-5fd8-e063-6394a90a26bd2025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - DeepHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4739179e-88b3-8820-e063-6394a90aa2112025-12-30WarningsExact identifier
application number: M020
WHITE TEA TINTED MOISTURIZERWHITE TEA TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREENGLOW CONCEPT INCeb2df93f-6cdc-7ae8-e053-2a95a90a00912025-12-29WarningsExact identifier
application number: M020
Hawaiian Natural Zinc Sunscreen SPF 50ZINC OXIDEKokua Sun Care64a5589b-735d-38ba-e053-2a91aa0ad8f42025-12-29WarningsExact identifier
application number: M020
Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30ZINC OXIDEKokua Sun Caref9a12dac-2fd0-798f-e053-6394a90aa7842025-12-29WarningsExact identifier
application number: M020
Calming Days Vegan Sunscreen,OCTYL TRIAZONE (ETHYLHEXYL TRIAZONE), BISOCTRIZOLE, DIETHYLHEXYL BUTAMIDO TRIAZONE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEMERCYCO Co., Ltd.38898014-eefe-73ec-e063-6394a90a37382025-12-29WarningsExact identifier
application number: M020
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 20SUNSCREEN OILSoleil Collective LLC471b3028-2c13-ab70-e063-6394a90aa6602025-12-29WarningsExact identifier
application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 45SUNSCREEN OILSoleil Collective LLC471c0eed-f7ca-3c3b-e063-6294a90ad2c62025-12-29WarningsExact identifier
application number: M020
EIGHT HOUR NOURISHING LIP SPF 20OCTINOXATE, AVOBENZONEREVLONb3c16e60-752d-6eba-e053-2995a90a2b202025-12-29WarningsExact identifier
application number: M020
CERAMIDE PREMIERE BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONEREVLONb3358bfd-7fe5-33e2-e053-2a95a90ac2ea2025-12-29WarningsExact identifier
application number: M020
Prevage anti aging SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE,Revlonb2bff796-1579-2686-e053-2995a90ad6c72025-12-29WarningsExact identifier
application number: M020
FLAWLESS FUTURE SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, AVAOBENZONEREVLONb553aec1-5002-3a3f-e053-2995a90a22e52025-12-29WarningsExact identifier
application number: M020
Prevage Anti-aging eye cream SPF 15OCTINOXATE, OXYBENZONERevlonb2a92d72-e634-7379-e053-2995a90a2bca2025-12-29WarningsExact identifier
application number: M020
Prevage Anti-aging Moisture CreamOCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONERevlon Consumer Products Corpb247adbe-dfe8-df0a-e053-2995a90a34d92025-12-29WarningsExact identifier
application number: M020
Sheer Protection SPF 30ZINC OXIDESkin Script, LLC0450dcc9-3f8f-e2c2-e063-6294a90af60b2025-12-29WarningsExact identifier
application number: M020
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC897b8edb-f089-4a49-baca-e05806b0a0682025-12-29WarningsExact identifier
application number: M020
Mine Line Coconut Sunscreen SPF 50ZINC OXIDESpa de Soleil4642b1cc-43b1-6997-e063-6394a90ac7642025-12-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0300-50003160300501 TUBE in 1 CARTON (0316-0300-50) / 50 mL in 1 TUBE1 tube2022-10-250000-00-00NoNoCurrent