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 273 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bali Body Cacao Tanning Oil SPF 15OCTOCRYLENE, OCTISALATE, AVOBENZONEBali Body Pty Ltd03c0b83d-0d85-9e69-e063-6394a90a61422024-10-21WarningsExact identifier
application number: M020
ALDI LACURA KIDS SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCe34f37d7-02a5-0b72-e053-2a95a90acf832024-10-21WarningsExact identifier
application number: M020
Aldi Lacura Ultra Light Body SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEALDI INCf7ac082c-def8-4379-e053-6294a90a57e32024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Sport Sunscreen 30 Broad Spectrum SPF 30 ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCf7bdc1f7-d961-4596-e053-6394a90a1d872024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Ultra Light Dry-Touch 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEALDI INCf7b2cf4e-468c-3406-e053-6394a90a21392024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Sport Sunscreen 50 Broad Spectrum SPF 50 ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCf7b32aa8-2e56-3725-e053-6294a90a18d22024-10-21WarningsExact identifier
application number: M020
Bliss Block Star Sheer Liquid Daily Sunscreen SPF 50 SPF-50ZINC OXIDEBliss Products Holdings LLCf262e5a7-3c57-a6d8-e053-2995a90aacbc2024-10-21WarningsExact identifier
application number: M020
Berkley Jensen Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBJWCfbd65277-7aff-de19-e053-6394a90a94962024-10-21WarningsExact identifier
application number: M020
Sun Bum SPF 15 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC01bfe44c-655f-404c-981e-8d5f6728a7382024-10-21WarningsExact identifier
application number: M020
Sun Bum SPF 70 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLCaa612570-b70a-4910-8086-6634834beb702024-10-21WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLCf5bd673a-46e5-43d5-9d76-8ddc5da701462024-10-21WarningsExact identifier
application number: M020
Sun Bum Kids Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLC6fcec9f9-bee0-4884-8c72-be273426f9162024-10-21WarningsExact identifier
application number: M020
sunscreenSKIN BARRIER SUN SHIELD SPF 30True Botanicals, Inc.d70eea23-7715-c17b-e053-2a95a90a839f2024-10-18WarningsExact identifier
application number: M020
First Aid Only SunX30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcme United Corporation24c22903-8911-81d9-e063-6394a90a108b2024-10-18WarningsExact identifier
application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD33f8760c-2953-44a6-9239-424fdb97a5b32024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c85e5094-d442-55a9-e053-2995a90aed122024-10-18WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.24c78897-3136-f24b-e063-6394a90aa80a2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f42a0b1e-038d-4fab-e053-2995a90a53642024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Manuka Honey and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f451c472-1d9f-1fbc-e053-2995a90a114e2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenZINC OXIDEFruit Of The Earth, Inc.f4490608-6cce-90f3-e053-2995a90a49302024-10-18WarningsExact 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