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
2027-12-31
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
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
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 159 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8dff782f-7201-4ad9-94d2-672058f817b82025-11-19WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e36351-4caf-3393-e063-6394a90a00b12025-11-18WarningsExact identifier
application number: M020
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e454cf-dac8-4c2f-e063-6394a90a70972025-11-18WarningsExact identifier
application number: M020
Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEH.E.B.43e55eb7-6572-bd88-e063-6294a90aa7ee2025-11-18WarningsExact identifier
application number: M020
ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMerle Norman Cosmetics, Inc.d10272ea-aedd-5759-e053-2a95a90a3ab32025-11-18WarningsExact identifier
application number: M020
DAYDREAM Broad Spectrum Sunscreen SPF 40ZINC OXIDEDrmtlgy, LLCbd0981cb-49ce-4eaf-bd9e-db48f56b73142025-11-18WarningsExact identifier
application number: M020
SPF 25 LIP BALMAVOBENZONE, OCTISALATE, HOMOSALATEDrmtlgy, LLC8aed2fb0-f7b8-4ff0-b597-144c0557789e2025-11-18WarningsExact identifier
application number: M020
Sunny Defense Sunscreen StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd262450f0-c4a1-dcca-e063-6394a90ae3cd2025-11-17WarningsExact identifier
application number: M020
Tone Blur Essence SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd1814b5e7-5bbf-df16-e063-6294a90a96c42025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c48c66-bd5b-0024-e063-6394a90a6c7b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c512da-e4b6-dd9c-e063-6294a90a17302025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c52258-2549-c42b-e063-6394a90a15262025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c59de6-8eb2-d00a-e063-6294a90a0b042025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5bd02-62e0-019a-e063-6294a90adcf32025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5d54e-119c-0c6d-e063-6394a90aba4c2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5eb1c-b268-acfb-e063-6394a90ad4cc2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6157a-4b62-8279-e063-6294a90abe052025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6252f-56b8-9e3c-e063-6294a90aa12c2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c62e80-9ace-c1f2-e063-6294a90a5bfa2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6864c-bc8e-e900-e063-6294a90a7a142025-11-17WarningsExact 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