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
2027-12-31
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
2027-12-31

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 142 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foam Weightless Sunscreen Non-Tinted Drytouch NTTITANIUM DIOXIDE, ZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC335ec22c-6a9a-c4d1-e063-6394a90ac0b02025-12-09Exact identifier
application number: M020
Mineral Sunscreen Moisturizing Non-TintedZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC3360a208-5f17-a74b-e063-6294a90a13e12025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD323356ea-31a0-6ff0-e063-6294a90a135c2025-12-09Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD32330376-5db0-202b-e063-6294a90add152025-12-09Exact identifier
application number: M020
Sunscreen Plus UntintedZINC OXIDELily Lee, MD32354468-94a2-604b-e063-6394a90adfb52025-12-09Exact identifier
application number: M020
Sunscreen Plus TintedZINC OXIDELily Lee, MD32346536-f542-ef0f-e063-6394a90a04642025-12-09Exact identifier
application number: M020
Sunscreen Plus Mineral Stick UntintedTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD3234b498-5b56-55f4-e063-6294a90a9b872025-12-09Exact identifier
application number: M020
Sunscreen Plus TintedZINC OXIDELily Lee, MD3235a696-92aa-788c-e063-6394a90a01492025-12-09Exact identifier
application number: M020
Sunscreen Plus Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD32351db0-884c-8fa0-e063-6294a90acba22025-12-09Exact identifier
application number: M020
Sunscreen Plus UntintedZINC OXIDELily Lee, MD3235786d-7ba9-c9ab-e063-6294a90a7f2e2025-12-09Exact identifier
application number: M020
Tinted Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC31416d04-2d6f-7cf9-e063-6294a90a98062025-12-09WarningsExact identifier
application number: M020
Matte Invisible Mineral Sunscreen Non-TintedZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3143968a-096e-b9ac-e063-6294a90ada0d2025-12-09WarningsExact identifier
application number: M020
Daily Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC314299b1-a78b-c1bd-e063-6294a90ab43b2025-12-09WarningsExact identifier
application number: M020
Sheer Satin Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3143d8b0-4af8-f52d-e063-6294a90a926b2025-12-09WarningsExact identifier
application number: M020
Matte Invisible Mineral SunscreenZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3142ed0f-f379-f240-e063-6294a90a53032025-12-09WarningsExact identifier
application number: M020
Sheer Non-Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEFace Collection, L.L.C.33d83cfb-045d-141c-e063-6394a90a2e042025-12-09Exact identifier
application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company45875865-5e9c-d652-e063-6394a90ad5fa2025-12-09WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b7584-c782-fe9e-e063-6394a90a76fe2025-12-09Exact identifier
application number: M020
Transparent Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEFace Collection, L.L.C.33dbfd9b-b90f-bb32-e063-6294a90af7dc2025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b46ac-6dde-72d1-e063-6294a90a03da2025-12-09Exact 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