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 110 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mattifying Mineral SPF40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d4f6a7-1115-1efa-e063-6294a90a20c42025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d69eb5-597d-14a0-e063-6394a90a0a492025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d45700-fc41-ef54-e063-6394a90abcc32025-12-17Exact identifier
application number: M020
Gentle Mineral SPF 40 TintedZINC OXIDEELIZA ARAKELIAN36d66cde-1f90-32b5-e063-6294a90acb342025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d7148b-b1c4-a6a9-e063-6294a90af92f2025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d85902-fbd2-ba74-e063-6294a90acfc32025-12-17Exact identifier
application number: M020
DAY DEFENSETITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad1330-a8bf-e8f8-e063-6394a90acb022025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d9a8f3-7760-57f3-e063-6394a90a1a1e2025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d7a18b-5a12-84a9-e063-6394a90a7e382025-12-17Exact identifier
application number: M020
DAY DEFENSE TINTEDTITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad4442-e45f-90e2-e063-6294a90aeef52025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d8b849-cf73-e008-e063-6394a90a410a2025-12-17Exact identifier
application number: M020
TINTED RESTORATIVE MOISTURIZERZINC OXIDESKINERGIX LLC3636adf0-c3bd-7422-e063-6394a90aaccc2025-12-17Exact identifier
application number: M020
Premier ZincZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb378c8-14b0-aa13-e063-6294a90a4db32025-12-17WarningsExact identifier
application number: M020
Protect and RenewZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb479ed-1153-8e80-e063-6294a90a29372025-12-17WarningsExact identifier
application number: M020
Flawless FinishTITANIUM DIOXIDE, ZINC OXIDEENSO SKINCARE & WELLNESS LLC3b8df7ce-e5ce-aaf8-e063-6394a90afdae2025-12-17WarningsExact identifier
application number: M020
Shield Mineral Sunscreen TintedZINC OXIDESMOOTHE LLC369b9d76-f6c3-e25f-e063-6294a90adaf32025-12-17Exact identifier
application number: M020
Shield Mineral Sunscreen Non TintedZINC OXIDESMOOTHE LLC369bc20d-7192-7c0a-e063-6294a90a3dfe2025-12-17Exact identifier
application number: M020
Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d63a9-b9a9-9530-e063-6394a90ac8ef2025-12-17Exact identifier
application number: M020
Matte TintTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369ced69-59b4-0f3c-e063-6294a90a582f2025-12-17Exact identifier
application number: M020
Hydra TintZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d4e7a-8356-8f15-e063-6394a90acca82025-12-17Exact 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