FDA.reportPublic FDA data

BIO SPECTRA

Product NDC
61649-110
11-digit product format
616490110
Labeler code
61649
Product ID
61649-110_273701b7-3462-bd2d-e063-6294a90a1a94
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
9055-7588 Quebec Inc. DBA Attitude
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-11
Substance
ZINC OXIDE
Active strength
20 g/100g
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
BIO SPECTRA
Brand name suffix
ATTITUDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
954713fe-c84c-41b4-913d-3507ed91e55dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61649-110-15BIO SPECTRAATTITUDE150 g in 1 TUBECREAM1505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-110BIO SPECTRA ATTITUDE (ZINC OXIDE) CREAM [9055-7588 QUEBEC INC. DBA ATTITUDE]5Current NDC, Legacy NDC, 1 package rows20241120_954713fe-c84c-41b4-913d-3507ed91e55d.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 199 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lipid Shield SPF 30ZINC OXIDEAllure Labs3bce820a-147b-5d8b-e063-6294a90a570d2025-08-07WarningsExact identifier
application number: M020
GR LONGSTAY Matte Face Powder SPF 15OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI62759398-4935-4732-b950-cfbeab82bc5a2025-08-07WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry-Touch Sunscreen MAX Broad Spectrum SPF 100 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC3bac8d0a-8726-46c3-e063-6294a90a10752025-08-06WarningsExact identifier
application number: M020
Tanning Club Golden Glow Tanning Oil SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENETANNING CLUB, LLC33478e28-b079-4e52-9924-845d127be2862025-08-06WarningsExact identifier
application number: M020
Tanning Club Everyday Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONETANNING CLUB, LLC805048c4-f2b3-4d35-8674-f44cf3d1a4b52025-08-06WarningsExact identifier
application number: M020
PoolBar I Scream For Sunscreen SPF 50 Coconut and VanillaAVOBENZONE, OCTISALATE, OCTOCRYLENEPOOLBARdeddb91d-b2d5-4d97-bc38-5c11abde9d432025-08-06WarningsExact identifier
application number: M020
PoolBar I Scream For Sunscreen SPF 30 Coconut and VanillaAVOBENZONE, OCTISALATE, OCTOCRYLENEPOOLBAR7f16b91d-29e4-4c21-a008-5dcc858c83d82025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 17W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L053cb3cd-dd16-4d08-b347-a4349fa37c072025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 14W Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L7bf90657-b636-41d6-b96c-88d174989f5b2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 15N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lda7e19cd-6a8b-47df-bfc9-2f0f11b7955c2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 16N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf7a1d379-6de0-4be4-84a9-e0ebef332bef2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 18N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L671be8a6-51b7-45d2-9fff-c7736d2eea3e2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 19W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9efa5db5-d774-4089-895c-9667eda0f11b2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 20C MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L76232666-e23f-4842-bd0d-37819739ec3a2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 21W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L876b9a5d-dae3-47f1-9da6-b5e179fd28cd2025-08-06WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 50 Zinc Oxide Continuous SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3bba29ab-0e08-b751-e063-6294a90adb7b2025-08-06WarningsExact identifier
application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTSTITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC3bba70e9-da29-f43b-e063-6294a90a08ef2025-08-06WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0127f290-8c5e-4285-e063-6294a90ae1282025-08-06WarningsExact identifier
application number: M020
GR HD FOUNDATION HIGH DEFINITION SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIe36550a6-a231-41a8-abda-afdbb2449eaa2025-08-06WarningsExact identifier
application number: M020
GOLDEN ROSE CORRECT AND CONCEAL Concealer Cream PaletteOCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIcca417c8-b882-48a7-8bd8-ccc6f961a3d22025-08-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61649-110-1561649011015150 g in 1 TUBE (61649-110-15) 150 g2023-12-110000-00-00NoNoCurrent