FDA.reportPublic FDA data

Sunscreen SPF50

Product NDC
82123-014
11-digit product format
821230014
Labeler code
82123
Product ID
82123-014_495e0d14-b3c3-42c0-e063-6394a90a89fe
Type
HUMAN OTC DRUG
Nonproprietary name
Non Nano Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-28
Substance
ZINC OXIDE
Active strength
18.9 g/80mL
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
Sunscreen SPF50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE18.9 g/80mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
O414PZ4LPZInternal UNII lookup
K89MJ0S5VYInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5d52f13-a649-9579-e053-2a95a90a062cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82123-014-80Sunscreen SPF5080 mL in 1 TUBECREAM809
82123-014-81Sunscreen SPF501 in 1 TUBECREAM19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82123-014PROPOLIS NASAL PLUS (PLUS NASAL) LIQUID PROPOLIS NASAL (NASAL) LIQUID SUNSCREEN SPF50 (NON NANO ZINC OXIDE) CREAM SUNSCREEN FOR FACE SPF50 (NON NANO ZINC OXIDE) CREAM AFTERSUN (NON NANO ZINC OXIDE) CREAM DIAPER RASH CREAM (NON NANO ZINC OXIDE) CREAM SUNSCREEN FOR KIDS SPF50 (NON NANO ZINC OXIDE) CREAM S.O.S CREAM INTENSIVE MOISTURIZING SKIN PROTECTANT (NON NANO ZINC OXIDE) CREAM ACNE CONTROL SERUM (SALICYLIC ACID) LIQUID [SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI]8Current NDC, 2 package rows20240907_c5d52f13-a649-9579-e053-2a95a90a062c.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 234 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENEW SEASON DERMATOLOGY, PLLCfecd72a3-c7e5-3dfa-e053-6394a90a73572025-01-09WarningsExact identifier
application number: M020
ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L41b3cf18-dc11-4e1d-802e-5ba25bd87adb2025-01-09WarningsExact identifier
application number: M020
ECLIPSE SPF 50 PERFECTINT BEIGETITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLCb69dda25-372f-15d9-e053-2995a90a8d3e2025-01-09WarningsExact identifier
application number: M020
PerfecTint Powder SPF 40 All ShadesZINC OXIDEScience of Skincarebb26c010-299e-3dc5-e053-2995a90a2c892025-01-09WarningsExact identifier
application number: M020
Extreme Protect SPF 40 All ShadesZINC OXIDE, TITANIUM DIOXIDEScience of Skincare, LLC.b69db78b-5f0e-8ca2-e053-2a95a90ac88c2025-01-09WarningsExact identifier
application number: M020
ECLIPSE SPF 50 ALL SHADESTITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLC49df51e6-be9a-41be-b3e1-bfc062aaceaa2025-01-09WarningsExact identifier
application number: M020
CoTZ Mineral Suns Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD44a6ff9b-8067-4f32-acb2-4ede54c79e6e2025-01-09WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNKISSEDZINC OXIDE SUNSCREENBentley Laboratories, LLCc45b59d8-0196-4dce-bfaa-57c47f655fe82025-01-09WarningsExact identifier
application number: M020
TiZO Tinted Lip Protection SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a22025-01-09WarningsExact identifier
application number: M020
CoTZ Face Prime and Protect SPF 40 (Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1088fbf6-5790-490d-b272-ec281b4b76fa2025-01-09WarningsExact identifier
application number: M020
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDf106f52b-2157-46c7-9f7c-50f43a6490502025-01-09WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKSZINC OXIDE SUNSCREENBentley Laboratories, LLC5c98bacb-8bbd-47b8-8987-50be1ed34fc02025-01-09WarningsExact identifier
application number: M020
CoTZ Face MoistureZINC OXIDEFallien Cosmeceuticals, LTDdb682516-6c8f-4009-a9ec-e21dfc64ce152025-01-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light MediumOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautybcd22c9a-2db6-4653-9ab5-825f3f5cc4202025-01-08WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 LightOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautyc66c2a54-97c8-4904-a44a-b3cf790837f52025-01-08WarningsExact identifier
application number: M020
Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETempo Industries, Inc.af9aa56d-2f8a-55b9-e053-2a95a90a32582025-01-08WarningsExact identifier
application number: M020
Baby Mineral Sunscreen Probiotics SPF55ZINC OXIDEHello Bello0191b2e4-bcc5-541a-e063-6294a90a0e782025-01-08WarningsExact identifier
application number: M020
Kids Face and Body Sunscreen SPF 50ZINC OXIDEHello Bello01cc4ea0-e3de-32f1-e063-6394a90a13752025-01-08WarningsExact identifier
application number: M020
Baby Mineral Sunscreen SPF55ZINC OXIDEHello Bello0190eeaf-c5a0-3253-e063-6294a90a43c42025-01-08WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50ZINC OXIDEHello Bello01cc205b-a345-262a-e063-6394a90a955c2025-01-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82123-014-808212300148080 mL in 1 TUBE80 mlHistorical
82123-014-81821230014811 TUBE in 1 TUBE (82123-014-81) / 80 mL in 1 TUBE (82123-014-80) 1 tube2021-06-28NoNoCurrent