PROTEKT SPF-50 Sheer Mineral Sunscreen

Product NDC
82912-322
11-digit product format
829120322
Labeler code
82912
Product ID
82912-322_48c0c89a-eeb6-e9dd-e063-6394a90a7236
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Protekt Products, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-01
Substance
ZINC OXIDE
Active strength
180 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
PROTEKT SPF-50 Sheer Mineral Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE180 mg/mL

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
6edc0941-bb21-4797-a875-81f727694774Available 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
82912-322-00PROTEKT SPF-50 Sheer Mineral Sunscreen88 mL in 1 TUBECREAM884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82912-322PROTEKT SPF-50 SHEER MINERAL SUNSCREEN (ZINC OXIDE) CREAM [PROTEKT PRODUCTS, INC.]3Current NDC, Legacy NDC, 1 package rows20231112_6edc0941-bb21-4797-a875-81f727694774.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 24 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 SunscreenENSULIZOLEL'Oreal USA Products Inc79fd34ad-cd4a-4fa0-9b7c-e0a2252654da2026-05-27WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 SunscreenENSULIZOLESICOS ET CIE3ff286c0-4515-4cab-9b93-a782545b2f362026-05-27WarningsExact identifier
application number: M020
MyDerm SPF 50HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%Inspec Solutions LLC1a995cda-dc67-419c-90e6-c61050c760982026-05-27WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc2b634b3f-0d2b-4ae4-b302-9befb14a90df2026-05-27WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEfce593a2-f4ed-46c1-81a1-be3941649e472026-05-27WarningsExact identifier
application number: M020
BROTEGE Good Boy Protection SPF 15 and Retinol Daily MoisturizerBENZOPHENONE-3, BUTYLE METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENESpa de Soleil1f47e508-58dd-fab4-e063-6394a90a668a2026-05-27WarningsExact identifier
application number: M020
GOONGBE Waterful SunLotion Mild SPF 40ZINC OXIDEZero to Seven Inc.1e86edfd-d089-ba41-e063-6294a90a67092026-05-27WarningsExact identifier
application number: M020
GOONGBE Baby Easy Wash SunLotion SPF 30ZINC OXIDEZero to Seven Inc.1e86c2a9-a5c3-95cb-e063-6394a90a014d2026-05-27WarningsExact identifier
application number: M020
Stream2Sea Reef Safer Mineral Sunscreen SPF40ZINC OXIDEStream2Sea, LLC52e73c23-75ec-d8a8-e063-6294a90a54932026-05-27WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - RosewoodZINC OXIDERiversol52b8f588-8383-634e-e063-6294a90a8f8b2026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PoppyZINC OXIDERiversol52b92725-6d9a-768a-e063-6394a90ac9332026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - Jazzy BerryZINC OXIDEOdacite52b97fb0-84d6-a408-e063-6294a90a9be92026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - True NudeZINC OXIDEOdacite52b9be2a-4958-f537-e063-6294a90a7a1b2026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PoppyZINC OXIDESolesence, Inc.52ba09cb-edcc-a405-e063-6394a90a6aab2026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - Bubble GumZINC OXIDEOdacite52b9fb0a-0554-0de2-e063-6294a90a09d32026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - RosewoodZINC OXIDESolesence, Inc.52ba07f1-b74e-a4b6-e063-6394a90a74732026-05-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 50 SunscreenZINC OXIDESKIN DAMAGE INC.52ba2f12-839f-cea1-e063-6394a90a5ae62026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Bronze JolieZINC OXIDEOdacite52ba360e-375c-0469-e063-6294a90a020e2026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Golden HourZINC OXIDEOdacite52ba8e03-1944-b73d-e063-6294a90a50392026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Sienna RoseZINC OXIDEOdacite52ba7f12-2b79-79cf-e063-6294a90a92d82026-05-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82912-322-008291203220088 mL in 1 TUBE (82912-322-00) 88 ml2022-07-010000-00-00NoNoCurrent