FDA.reportPublic FDA data

Mineral Sunscreen Stick SPF 50

Product NDC
79753-032
Requested package NDC
79753-032-01
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 220 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Superactive Moisturizer SPF 50 Brightening SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC4ff8525a-4526-4acf-86c7-88f1f10732742025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 UnflavoredLIP BALM SPF15LS Promotions Inc3131632d-735c-6688-e063-6294a90a02392025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Chocolate Sundae flavoredLIP BALM SPF15LS Promotions Inc3142f352-ee65-47b5-e063-6394a90ada572025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Pina Colada flavoredLIP BALM SPF15 PINA COLADA FLAVOREDLS Promotions Inc31440153-e7ca-1327-e063-6294a90a562c2025-03-26WarningsExact identifier
application number: M020
CVS Health Sport 100 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY0a245b1b-eaf6-7011-e063-6294a90ab68f2025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Apple Pie flavoredLIP BALM SPF15 APPLE PIE FLAVOREDLS Promotions Inc3145bd6d-0ece-e9d5-e063-6294a90afb9d2025-03-26WarningsExact identifier
application number: M020
HEB Glow 40 Tinted Sunscreen Face PrimerAVOBENZONE, OCTISALATE, OCTOCRYLENEH.E.B.3146bcd9-d562-9ba6-e063-6294a90a37aa2025-03-26WarningsExact identifier
application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide SunscreenZINC OXIDEH.E.B.3146fb5f-1fb5-f09f-e063-6294a90a62062025-03-26WarningsExact identifier
application number: M020
HEB 50 Glow Body Oil SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.31473cc9-08f5-39e3-e063-6294a90aa4992025-03-26WarningsExact identifier
application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide SunscreenZINC OXIDEH.E.B.314776a8-a562-3dd2-e063-6394a90ab1b92025-03-26WarningsExact identifier
application number: M020
TRADER JOES INVISIBLE BODY SUNSCREEN SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company31478f5a-88f4-4b01-e063-6394a90a04b72025-03-26WarningsExact identifier
application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company3147c08f-c3f2-aef1-e063-6294a90a5c442025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Mangonada Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B3147ef18-9029-6d5b-e063-6394a90acee02025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Mexican Vanilla Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B31487bad-a756-9050-e063-6394a90acacc2025-03-26WarningsExact identifier
application number: M020
TRADER JOES DAILY FACIAL MINERAL SUNSCREEN SPF 40ZINC OXIDETrader Joe's Company3148c00f-21bb-c05f-e063-6394a90af0e82025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Chamomile and Lavender Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314b8147-fe7a-0698-e063-6394a90a872c2025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Shine Sunscreen with Vitamin C Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314bcf42-ca01-0fa5-e063-6294a90a5fc82025-03-26WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Hydrating SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC1e5d494b-dccf-4ba1-89de-0bb4ba5b8d382025-03-26WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Wrinkle Fighting SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEMurad, LLCac6163fb-dbc1-432f-a590-86d31c93b29b2025-03-26WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact 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