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 130 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Satin TintZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359684cf-ca11-f9af-e063-6394a90ac4c12025-12-12Exact identifier
application number: M020
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
application number: M020
JAYSUING Rice Probiotics SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.45cdc741-9ce0-fd6c-e063-6294a90adc0b2025-12-12WarningsExact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
application number: M020
Signature Tint SPF 40ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348f1bd3-1245-2d9a-e063-6394a90a47872025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348fcc63-d8e3-90a1-e063-6294a90ade112025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a54441-c741-0c46-e063-6294a90a9be82025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37620171-140d-e096-e063-6294a90af93b2025-12-11Exact identifier
application number: M020
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a52011-b781-75cf-e063-6394a90ae0f42025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a632f5-4458-e335-e063-6394a90a9bcb2025-12-11Exact identifier
application number: M020
D FEND DAILYZINC OXIDECLEAN BEAUTY BY ANAK LLC3762dc16-055e-43fd-e063-6394a90ad3c82025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a66140-0d36-005a-e063-6394a90a2a0b2025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37634726-fb70-f209-e063-6294a90a5d3b2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3761d74c-0137-0c75-e063-6394a90a3c7d2025-12-11Exact identifier
application number: M020
Sun Plus Sun Lip ShieldTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3763a79a-e881-cade-e063-6394a90a49de2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact identifier
application number: M020
Non Tinted Mineral SunscreenZINC OXIDESPECKTRA6 LLC374e1c8e-5c5c-9198-e063-6294a90a3b882025-12-11Exact 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