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 139 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AL0043600 Alba Botanica VE Herbal Healing BodyCOLLOIDAL OATMEALThe Hain Celestial Group, Inc.60672feb-141f-651e-e053-2a91aa0af41d2025-12-10WarningsExact identifier
application number: M020
UV Defense me. Matte Airy-Fit SunscreenZINC OXIDEMAGNIF CO., LTD459f2b8d-453c-4dee-e063-6394a90a45092025-12-10WarningsExact identifier
application number: M020
RoC Hydration Plus SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoc Skincare45a3e250-8195-344d-e063-6294a90ae6812025-12-10WarningsExact identifier
application number: M020
ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoc Skincarebf3c1474-e353-63a5-e053-2a95a90a9b262025-12-10WarningsExact identifier
application number: M020
ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoc Skincaref161d754-0c32-2fbe-e053-2a95a90a6b472025-12-10WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242ff053-b8c0-4f90-e063-6294a90a7bb32025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORYOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ef1f8-ad12-4f80-e063-6394a90a3e3c2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.e810d366-0c32-5b1c-e053-2a95a90a622e2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242b7d0e-82d8-793c-e063-6294a90a4aa32025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.eb744367-f318-e1e2-e053-2a95a90a2cc42025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242faaed-e85a-a1d7-e063-6294a90aea922025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247d6c0e-8f88-faf0-e063-6394a90a10da2025-12-09WarningsExact identifier
application number: M020
AGE20S UV DEFENSE HYDRO CALMING SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAekyung Industrial Co., Ltd.1e9a5c77-7027-3b52-e063-6394a90ac0eb2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.e8241828-17b2-96c5-e053-2a95a90a12e52025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.1176181b-1331-ba68-e063-6394a90a961a2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247b56ad-4b61-8b6f-e063-6394a90af3b62025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247afcae-855e-3f69-e063-6394a90a42312025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.24306304-4d0d-c5f0-e063-6394a90afad52025-12-09WarningsExact identifier
application number: M020
AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN TWIN PACKOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAekyung Industrial Co., Ltd.1f9c7718-6fde-236c-e063-6394a90afa192025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3482855b-de85-a5a7-e063-6294a90a55ae2025-12-09WarningsExact 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