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 200 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GR SATIN SMOOTHING Fluid Foundation SPF 15OCTINOXATE, OXYBENZONEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI1eba51f2-782e-480e-8555-f5ad8883fa0d2025-08-06WarningsExact identifier
application number: M020
GR TOTAL COVER 2 in 1 Foundation and Concealer SPF 15OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI038ec45a-0d56-4cd9-8060-767b382c12372025-08-06WarningsExact identifier
application number: M020
GR CC Broad Spectrum SPF 30OCTINOXATE, OXYBENZONEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI751d5194-f5ea-401b-9439-7770510a588c2025-08-06WarningsExact identifier
application number: M020
GR NUDE LOOK SPF 25AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI96dae912-8fa5-4d0e-b873-e1dbb7398db02025-08-06WarningsExact identifier
application number: M020
GR BB SPF 25OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI3b22579b-21ce-4b96-bd24-774ce35bf6f72025-08-06WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Invisible Gel Face Sunscreen SPF 40 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC3b9a4bd9-cbe1-60c5-e063-6394a90a58922025-08-05WarningsExact identifier
application number: M020
Neutrogena Hydro Boost City Shield water Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC77e4bbcc-0a51-4e9c-9328-46bcbf4f81292025-08-05WarningsExact identifier
application number: M020
Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCdecb4842-c880-0668-e053-2995a90aad7e2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 08W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L498bf941-67f2-41d5-a039-9f827b68297e2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 10N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L54e390bd-b84a-4c43-986e-74923e34689d2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 09C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L897024cd-576e-4a8e-8daa-92dc3bb4b3a52025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 11W Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L303967d1-9df8-4a8e-a264-6b0d8fdbf2a82025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 12N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L26062cd7-3817-46c7-b65f-92cd57eca5dd2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 13C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L448a24a3-91ef-4530-828c-e77d8aae7f0b2025-08-05WarningsExact identifier
application number: M020
JORDAN FAT KIDS Tallow Sunscreen SPF 30MENTHOL, METHYL SALICYLATEJORDAN FAT KIDS LLC72ac88cf-9f20-44ea-b3a2-12c922eec2b32025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 02C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L09f9e59b-6f71-4d42-9b5d-275f756d985b2025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 03W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3b1e4480-8409-425e-b98d-eb4dcf2471e82025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 06W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3090422e-fc18-45b8-88f2-6a9b282a72052025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 05N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf93aa5d2-90ab-4e11-874e-2ede4b25c4b62025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 04C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf055cd51-7b1d-43df-8990-8f60ba1eb91c2025-08-04WarningsExact 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