FDA.reportPublic FDA data

Alba Botanica Sheer Mineral SPF30

Product NDC
61995-2033
11-digit product format
619952033
Labeler code
61995
Product ID
61995-2033_4486a62d-6f4a-853f-e063-6294a90a6cee
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
The Hain Celestial Group, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-01
Substance
ZINC OXIDE
Active strength
24.1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage61995-2033-1
excluded packagepackage61995-2033-3
excluded packagepackage61995-2033-2

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
Alba Botanica Sheer Mineral SPF30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE24.1 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
0cf9361f-f292-6429-e063-6294a90add0eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61995-2033-12025-11-21AL00389, AL00441 Alba Botanica Minieal SPF 30 Formula PF163046-03
61995-2033-12025-11-21AL00389 Alba Botanica Sheer Minieal SPF 30 Formula PF163046-03
61995-2033-22025-11-21AL00389, AL00441 Alba Botanica Minieal SPF 30 Formula PF163046-03
61995-2033-22025-11-21AL00389 Alba Botanica Sheer Minieal SPF 30 Formula PF163046-03
61995-2033-32025-11-21AL00389, AL00441 Alba Botanica Minieal SPF 30 Formula PF163046-03
61995-2033-32025-11-21AL00389 Alba Botanica Sheer Minieal SPF 30 Formula PF163046-03
61995-2033-12025-07-29AL00389, AL00441 Alba Botanica Minieal SPF 30 Formula PF163046-03
61995-2033-12025-07-29AL00389 Alba Botanica Sheer Minieal SPF 30 Formula PF163046-03
61995-2033-22025-07-29AL00389, AL00441 Alba Botanica Minieal SPF 30 Formula PF163046-03
61995-2033-22025-07-29AL00389 Alba Botanica Sheer Minieal SPF 30 Formula PF163046-03
61995-2033-32025-07-29AL00389, AL00441 Alba Botanica Minieal SPF 30 Formula PF163046-03
61995-2033-32025-07-29AL00389 Alba Botanica Sheer Minieal SPF 30 Formula PF163046-03

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2033-1Alba Botanica Sheer Mineral SPF3059 g in 1 TUBELOTION595
61995-2033-2Alba Botanica Sheer Mineral SPF3089 g in 1 TUBELOTION895
61995-2033-3Alba Botanica Sheer Mineral SPF30113 g in 1 TUBELOTION1135

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2033ALBA BOTANICA SHEER MINERAL SPF30 (ZINC OXIDE) LOTION [THE HAIN CELESTIAL GROUP, INC.]3Current NDC, 3 package rows20240310_0cf9361f-f292-6429-e063-6294a90add0e.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 134 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Primer Anti-AgingTITANIUM DIOXIDE, ZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351aaaad-44ce-3558-e063-6294a90a2b462025-12-11Exact identifier
application number: M020
Total Body Block SunscreenZINC OXIDEADR SUNCARE38f4928c-6389-5aa1-e063-6294a90a8f9d2025-12-11Exact identifier
application number: M020
Magic VeilZINC OXIDETHE COMPLEXIONIST38f574ad-c4bf-fca1-e063-6394a90a00c52025-12-11Exact identifier
application number: M020
Magic VeilZINC OXIDETHE COMPLEXIONIST38f5a0b9-bbe2-50f4-e063-6294a90a10d72025-12-11Exact identifier
application number: M020
Daily Tinted Antioxidant Mineral SunscreenZINC OXIDEMONIKA G KIRIPOLSKY MD INC.3b3f19c1-4bff-315f-e063-6394a90a9a852025-12-11WarningsExact identifier
application number: M020
Daily Repair Moisturizing TintedZINC OXIDESkintique37dd83db-aa43-7f66-e063-6294a90a893b2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing Non TintedZINC OXIDESkintique37de01d0-7694-69c1-e063-6394a90acf0a2025-12-11Exact identifier
application number: M020
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37dd5228-5fe4-5e7b-e063-6294a90adffb2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing Non TintedZINC OXIDESkintique37ddc177-376d-b2fe-e063-6294a90a5e072025-12-11Exact identifier
application number: M020
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37de2f44-e0da-0d1c-e063-6294a90ae18b2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing TintedZINC OXIDESkintique37de5a51-0bc4-34ad-e063-6294a90a0eef2025-12-11Exact identifier
application number: M020
Mineral SunscreenZINC OXIDELEILANI VIDAL36d51157-1bcd-79c8-e063-6394a90aba712025-12-11Exact identifier
application number: M020
Mineral SunscreenZINC OXIDELEILANI VIDAL36d4b998-c29c-ff89-e063-6394a90a12d82025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEILANI VIDAL36d5831a-7128-729a-e063-6394a90a80362025-12-11Exact identifier
application number: M020
Mineral Matte Non-Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac219bd-dfc8-fe22-e063-6394a90a4a8c2025-12-11WarningsExact identifier
application number: M020
Tinted Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac25d06-d885-48a2-e063-6294a90a0d0b2025-12-11WarningsExact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac27b6c-1341-1f05-e063-6394a90a98602025-12-11WarningsExact identifier
application number: M020
Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37287e4c-6fdf-62c5-e063-6394a90a12962025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37284de3-32d4-3611-e063-6394a90a63932025-12-11Exact identifier
application number: M020
Mineral Lip Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST3728ec6a-7de5-bbc5-e063-6294a90a31b72025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61995-2033-16199520330159 g in 1 TUBE (61995-2033-1) 59 g2022-01-01NoNoCurrent
61995-2033-26199520330289 g in 1 TUBE (61995-2033-2) 89 g2022-01-01NoNoCurrent
61995-2033-361995203303113 g in 1 TUBE (61995-2033-3) 113 g2022-01-01NoNoCurrent