FDA.reportPublic FDA data

Botnia Gentle Sun SPF 30

Product NDC
87461-904
11-digit product format
874610904
Labeler code
87461
Product ID
87461-904_4c1e721a-a8f5-db1b-e063-6294a90a0a26
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Botnia, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-19
Substance
ZINC OXIDE
Active strength
180 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Botnia Gentle Sun SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE180 mg/mL

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
005d0245-fe53-47e5-888b-683f58cd6d26Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87461-904-00Botnia Gentle Sun SPF 3050 mL in 1 TUBECREAM501
87461-904-00Botnia Gentle Sun SPF 301 in 1 BOXCREAM11

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 27 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSICZINC OXIDEColorescienced46533c7-c92d-d161-e053-2995a90a8e4b2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield GlowZINC OXIDEColoresciencecdb5397a-c463-4b41-e053-2a95a90a9e032026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield MatteZINC OXIDEColoresciencecd879b3e-16a2-2cca-e053-2a95a90a14f82026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Body ShieldZINC OXIDEColoresciencecdb413bb-58ab-1e0f-e053-2995a90aab0f2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield FlexZINC OXIDEColoresciencecdb55347-aedd-4de6-e053-2a95a90afec72026-05-21WarningsExact identifier
application number: M020
Odacite Flex Perfecting Mineral Drops Tinted SunscreenZINC OXIDEOdacite52560b2d-ebb5-5d96-e063-6294a90a15ee2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield BronzeZINC OXIDEColoresciencecdb577e4-5c80-7eac-e053-2a95a90a105b2026-05-21WarningsExact identifier
application number: M020
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC52564e2f-983d-89ba-e063-6394a90ab4242026-05-21WarningsExact identifier
application number: M020
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
application number: M020
Agent Natuer holi (sun) dewy tinted skin dropsZINC OXIDEAgent Natuer043734b8-9aee-cdf1-e063-6294a90aec602026-05-21WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty09bb5f97-f4db-a2d4-e063-6394a90a84fd2026-05-21WarningsExact identifier
application number: M020
Skin Metal Green StealthZINC OXIDESkin Metal47f562cc-48cc-97f9-e063-6294a90a72162026-05-21WarningsExact identifier
application number: M020
Blume Sunburst SunscreenZINC OXIDEBlume21ef2c6b-8ae7-8bcf-e063-6294a90ae9e12026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST13 KAMARI)ZINC OXIDEIlia, Inc.b595ca2c-177e-b357-e053-2995a90a54f62026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST6 ORA)ZINC OXIDEIlia, Inc.b59537d4-e1d8-53e4-e053-2995a90a2ce32026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST16 PAVONES)ZINC OXIDEIlia, Inc.b595f1e9-36f7-615d-e053-2a95a90abb1c2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST2.5 SOMBRIO)ZINC OXIDEIlia, Inc.b97dc2ac-dd6d-403d-e053-2995a90a0d9c2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST14 DOMINICA)ZINC OXIDEIlia, Inc.b595db16-7969-726f-e053-2995a90ab7832026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST11 MATIRA)ZINC OXIDEIlia, Inc.b595b5f0-dd3d-79ef-e053-2a95a90ad9fb2026-05-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87461-904-00874610904001 TUBE in 1 BOX (87461-904-00) / 50 mL in 1 TUBE1 tube2026-01-19NoNoCurrent