FDA.reportPublic FDA data

Mineral Sunscreen Stick SPF 50

Product NDC
79753-032
11-digit product format
797530032
Labeler code
79753
Product ID
79753-032_45edd8cc-b74a-0dae-e063-6394a90a3cf2
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
COOLA LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-16
Substance
ZINC OXIDE
Active strength
13.63 g/100g
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

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
Mineral Sunscreen Stick SPF 50
Brand name suffix
Fragrance-Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE13.63 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
ee8706b0-ad42-403a-be7c-b660f040a244Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-032-01Mineral Sunscreen Stick SPF 50Fragrance-Free17 g in 1 CANISTERSTICK175
79753-032-01Mineral Sunscreen Stick SPF 50Fragrance-Free1 in 1 CARTONSTICK15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-032MINERAL SUNSCREEN STICK SPF 50 FRAGRANCE-FREE (ZINC OXIDE) STICK [COOLA LLC]4Current NDC, 2 package rows20241228_ee8706b0-ad42-403a-be7c-b660f040a244.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 175 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AussieZinc Mineral Sunscreen Vegan and Organic Hydrate and Nourish - Medium TintZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca1103-b9bf-2573-e063-6394a90acdc52025-10-23WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Extra SensitiveZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca5334-fd41-297f-e063-6394a90ac72e2025-10-23WarningsExact identifier
application number: M020
Mineral Sun DropsZINC OXIDESynchronicity Spa, Inc. DBA Suntegrityd8acda81-4430-42f8-be56-d28bb010e6302025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 LatteOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc34c1486-fa6c-485f-80b3-98e397b3dddb2025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool VanillaOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS74c078ec-a371-4406-8d5e-a0baada3a1a62025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 SandalwoodOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2765f345-eab2-4878-b1f1-f8e2430834762025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 ToffeeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASd1181543-07ab-4a51-8b55-afc1a98293f62025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc7be3a7e-f031-4ec0-b9dc-41c025cd00662025-10-22WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC41c0c262-21c3-b8e6-e063-6394a90a7c9c2025-10-22WarningsExact identifier
application number: M020
PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENESMASHBOX BEAUTY COSMETICS, INC41c4e135-c6df-82d4-e063-6294a90a0ad32025-10-22WarningsExact identifier
application number: M020
City Sunscreen serum Broad Spectrum SPF 30 SupergoopHOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.a29e5a69-d17e-45ef-8dde-e99c6e4a2b222025-10-22WarningsExact identifier
application number: M020
Miffy Sunny Defense SPF StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERBGROUP Co., Ltd24802b17-c0ba-1075-e063-6394a90addd52025-10-21WarningsExact identifier
application number: M020
Sunny Defense SPF StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd18632155-5feb-5759-e063-6294a90ab88c2025-10-21WarningsExact identifier
application number: M020
Paul Frank Sunny Defense SPF StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd26345203-3393-60ba-e063-6394a90a7e922025-10-21WarningsExact identifier
application number: M020
Keith Haring Tone Blur Essence SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERBGROUP Co., Ltd1d578196-c785-9914-e063-6394a90a05332025-10-21WarningsExact identifier
application number: M020
luminous aqua sunscreen mistAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd29fc0c2b-8d10-8704-e063-6394a90ad5042025-10-21WarningsExact identifier
application number: M020
DEWYTREE URBAN SHADE HYALURONIC LIGHTWEIGHT SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEDEWYTREE CO. ,LTD2f1ca6e0-f689-57c7-e063-6394a90a3da52025-10-21WarningsExact identifier
application number: M020
TOSOWOONG Rice Glow SunScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMANTONG Co., Ltd.3e9120fd-1c2f-1546-e063-6394a90a9e462025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - BuffHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.857666da-2b4a-4a4a-aa25-ed6fd9b6a1632025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - IvoryHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V62031860-2e28-4b25-82bd-29b874b24d842025-10-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79753-032-01797530032011 CANISTER in 1 CARTON (79753-032-01) / 17 g in 1 CANISTER1 canister2023-01-16NoNoCurrent