ALLSWELL MINERAL SUNSCREEN SPF 30

Product NDC
69555-043
11-digit product format
695550043
Labeler code
69555
Product ID
69555-043_2b8987c1-6b12-e72f-e063-6294a90a2440
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Stream2Sea, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-28
Substance
ZINC OXIDE
Active strength
22 g/1
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct69555-043UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69555-04369555-043-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
ALLSWELL MINERAL SUNSCREEN SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE22 g/1

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
03bee988-d6e3-4290-a926-9c5366649cbaAvailable 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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69555-043-01ALLSWELL MINERAL SUNSCREEN SPF 3051 in 1 TUBELOTION512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69555-043ALLSWELL MINERAL SUNSCREEN SPF 30 (ZINC OXIDE) LOTION [STREAM2SEA, LLC]2Current NDC, 1 package rows20250114_03bee988-d6e3-4290-a926-9c5366649cba.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 258 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everyday Coverage Tinted Sunscreen - Extra Light TintZINC OXIDEMV Advanced7834c649-5f6d-b005-e053-2a91aa0a10842024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Light TintZINC OXIDEMV Advanced783649af-d746-84a3-e053-2991aa0a9e3d2024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Medium TintZINC OXIDEMV Advanced783649af-d768-84a3-e053-2991aa0a9e3d2024-12-12WarningsExact identifier
application number: M020
Babo SPF 30 Clear Zinc Fragrance Free SportMINERAL SUNSCREENBabo Botanicals, Inc.b1a9f76d-0cef-29da-e053-2995a90af34c2024-12-12WarningsExact identifier
application number: M020
Babo Baby Face Mineral SunscreenMINERAL SUNSCREENBabo Botanicals, Inc.b131664d-1ad2-0a2f-e053-2995a90acbda2024-12-12WarningsExact identifier
application number: M020
Babo SPF 30 Clear Zinc Fragrance FreeMINERAL SUNSCREENBabo Botanicals, Inc.b3e40cb0-dbfd-955c-e053-2995a90af8482024-12-12WarningsExact identifier
application number: M020
DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30ZINC OXIDEBABOR Cosmetics America Corp291ec801-ee15-06a4-e063-6294a90ab32b2024-12-12WarningsExact identifier
application number: M020
All Calm Clinical Redness Corrector SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColorescience68b95e94-3686-4d11-9952-ec86394376ee2024-12-12WarningsExact identifier
application number: M020
Method Men Face with Zinc Oxide SunscreenZINC OXIDEMethod Products Inc.cce5f8e1-cf40-4524-af2b-1d49309e28092024-12-12WarningsExact identifier
application number: M020
Sunforgettable Tint du Soleil Foundation SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColorescience219e2ef4-e977-4527-8999-14b27d5a7a332024-12-12WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 50Plus SunscreenZINC OXIDEAbsolutely Natural4855c2c7-1516-4857-b103-2eb72a60d5d02024-12-11WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 30 SunscreenZINC OXIDEAbsolutely Naturalb6e8f361-fd31-4f21-9095-c5159a8261752024-12-11WarningsExact identifier
application number: M020
Walgreens Scar Cream w/SPF 30AVOBENZONE3%,OCTOCRYLENE10%,OXYBENONE 6%Walgreenscc72c8c5-f3e9-e8e0-e053-2a95a90ae0b02024-12-11WarningsExact identifier
application number: M020
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lee9ae84b-c8fc-4a87-8910-46ec8ccfe1a92024-12-11WarningsExact identifier
application number: M020
ERBORIAN - BB CREME AU GINSENG DORE SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L121aa873-5ca6-426b-8ece-dcb5a9f82a032024-12-11WarningsExact identifier
application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L3421b9a3-6551-406f-af3a-b3da8a01d2b22024-12-11WarningsExact identifier
application number: M020
ERBORIAN CC RED CORRECT SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELaboratoires M&L21530925-03b7-40bb-9836-6ee4011c4a792024-12-11WarningsExact identifier
application number: M020
ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMELOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L70a5537c-a364-4dae-8ab2-8ca0cbfd11b72024-12-11WarningsExact identifier
application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lb55be8cb-7f21-45b0-bb8f-a60182077ca32024-12-11WarningsExact identifier
application number: M020
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep HoneyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdc792777-d8b6-3ebc-e053-2a95a90abc3f2024-12-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69555-043-016955500430151 LOTION in 1 TUBE (69555-043-01) 51 lotion2023-03-28NoNoCurrent