FDA.reportPublic FDA data

Alba Botanica Sheer Mineral SPF50

Product NDC
61995-2035
11-digit product format
619952035
Labeler code
61995
Product ID
61995-2035_448656be-441d-468a-e063-6294a90a6e3c
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

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 SPF50
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
0cf9c4b9-8e85-980c-e063-6394a90a9e7eAvailable 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
61995-2035-12024-07-31AL01062, AL00656 Alba Botanica Minieal SPF 50 Formula PF163046-03
61995-2035-12024-07-31AL01062, AL01063 Alba Botanica Sheer Mineral SPF 50 Formula PF163046-03
61995-2035-22024-07-31AL01062, AL00656 Alba Botanica Minieal SPF 50 Formula PF163046-03
61995-2035-22024-07-31AL01062, AL01063 Alba Botanica Sheer Mineral SPF 50 Formula PF163046-03
61995-2035-32024-07-31AL01062, AL00656 Alba Botanica Minieal SPF 50 Formula PF163046-03
61995-2035-32024-07-31AL01062, AL01063 Alba Botanica Sheer Mineral SPF 50 Formula PF163046-03
61995-2035-12024-07-30AL01062, AL00656 Alba Botanica Minieal SPF 50 Formula PF163046-03
61995-2035-12024-07-30AL01062, AL01063 Alba Botanica Sheer Mineral SPF 50 Formula PF163046-03
61995-2035-22024-07-30AL01062, AL00656 Alba Botanica Minieal SPF 50 Formula PF163046-03
61995-2035-22024-07-30AL01062, AL01063 Alba Botanica Sheer Mineral SPF 50 Formula PF163046-03
61995-2035-32024-07-30AL01062, AL00656 Alba Botanica Minieal SPF 50 Formula PF163046-03
61995-2035-32024-07-30AL01062, AL01063 Alba Botanica Sheer Mineral SPF 50 Formula PF163046-03

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2035-1Alba Botanica Sheer Mineral SPF5059 g in 1 TUBELOTION595
61995-2035-2Alba Botanica Sheer Mineral SPF5089 g in 1 TUBELOTION895
61995-2035-3Alba Botanica Sheer Mineral SPF50113 g in 1 TUBELOTION1135

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2035ALBA BOTANICA SHEER MINERAL SPF50 (ZINC OXIDE) LOTION [THE HAIN CELESTIAL GROUP, INC.]2Current NDC, 3 package rows20240802_0cf9c4b9-8e85-980c-e063-6394a90a9e7e.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 112 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non Tinted Mineral SunscreenZINC OXIDENatur LLC365fffa2-b846-7dd3-e063-6394a90a47cb2025-12-16Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDENatur LLC36603550-9c3d-5e33-e063-6394a90adfc92025-12-16Exact identifier
application number: M020
Shield And Protect TintedZINC OXIDETRILOGY LABORATORIES, LLC37f00e51-1123-c04c-e063-6294a90abed82025-12-16Exact identifier
application number: M020
Shield And ProtectZINC OXIDETRILOGY LABORATORIES, LLC37f09dd5-084f-3c80-e063-6394a90a7a532025-12-16Exact identifier
application number: M020
Non Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766496f-231c-f98c-e063-6294a90aae082025-12-16Exact identifier
application number: M020
Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766b0d8-20e6-a227-e063-6294a90af4da2025-12-16Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC37515807-e29a-3916-e063-6394a90a1ffd2025-12-16Exact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC374f866d-eb52-61e3-e063-6394a90a77c72025-12-16Exact identifier
application number: M020
Tinted Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC3750c23d-c3f8-fac3-e063-6394a90a135e2025-12-16Exact identifier
application number: M020
Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40ZINC OXIDEWECARE FRISCO PLLC374fe86e-cbe8-f911-e063-6294a90a96002025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC37507b14-fc01-5e27-e063-6294a90afd502025-12-16Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC375203a6-2ab8-2a80-e063-6294a90ada722025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC3751caa3-867e-5901-e063-6294a90ab6bd2025-12-16Exact identifier
application number: M020
Auset Tinted Replenishing Daily ProtectionZINC OXIDESHAYLA BOGER SKIN THERAPY LLC37da48d6-8f12-ec97-e063-6294a90a699c2025-12-16Exact identifier
application number: M020
Morning ReplenishZINC OXIDEKATHY JONES AESTHETHICS LLC37da711e-840b-2f2a-e063-6294a90ab16c2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEKATHY JONES AESTHETHICS LLC37dab729-5988-5eba-e063-6294a90ac6b72025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETory Sullivan, M.D., P.A.36241e60-f02a-50a7-e063-6394a90a63902025-12-16Exact identifier
application number: M020
Ageless All FitzZINC OXIDEA.Wall Beauty LLC37670cb1-ac75-5049-e063-6394a90a4d0a2025-12-16Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDETory Sullivan, M.D., P.A.36244b27-20e5-f370-e063-6294a90a1f6c2025-12-16Exact identifier
application number: M020
UV Defense Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e09a8-308b-b753-e063-6394a90ae9e52025-12-16Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61995-2035-16199520350159 g in 1 TUBE (61995-2035-1) 59 g2022-01-01NoNoCurrent
61995-2035-26199520350289 g in 1 TUBE (61995-2035-2) 89 g2022-01-01NoNoCurrent
61995-2035-361995203503113 g in 1 TUBE (61995-2035-3) 113 g2022-01-01NoNoCurrent