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
K89MJ0S5VYInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
O414PZ4LPZInternal 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 164 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCa64045dd-8f70-43f1-be6f-ad1556c0e2102025-11-13WarningsExact identifier
application number: M020
TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15AVOBENZONE,HOMOSALATE,OCTISALATERenuskin LLCe36efd74-11c2-4850-9529-1c88b7364a332025-11-12WarningsExact identifier
application number: M020
TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80minAVOBENZONE,HOMOSALATE,OCTISALATERenuskin LLC22a40d93-ca67-4b7d-a95c-22f52cd6d2972025-11-12WarningsExact identifier
application number: M020
Practical Alchemy Hydrating SPF 30ZINC OXIDEOver Here, LLC2f07df5b-dbd4-494c-a7cf-55843fb4d7c22025-11-12WarningsExact identifier
application number: M020
Dr Lift SPF 50 Mineral Sunscreen StickZINC OXIDESpa de Soleil436fdf4f-11db-7c5b-e063-6294a90a87312025-11-12WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc3676aa91-c90d-4a7a-b02e-d5b35304a04d2025-11-12WarningsExact identifier
application number: M020
HYDRATING GLOW MIST SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTDdf3bd18d-63b4-460f-bf1c-115ad35edd962025-11-11WarningsExact identifier
application number: M020
Zinka Clear Zinc Oxide SunscreenOCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONEZinka, Inc.7b097f5e-8127-49e6-8a77-4ee1fded5ff12025-11-11WarningsExact identifier
application number: M020
Total Sun ProtectionOCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDECosmed Dermaceuticals, Inc.dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f2025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF15HOMOSALATE, OCTOCRYLENE, AVOBENZONEQS Key West Aloe, LLC1a1c17c4-4912-4573-9f59-cbd14a014cb42025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF30HOMOSALATE, OCTOCRYLENE, AVOBENZONEQS Key West Aloe, LLC14f65b3d-90bf-4689-aa6e-879e06153db92025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF50HOMOSALATE, ZINC OXIDE, OCTOCRYLENEQS Key West Aloe, LLCb4fc7a51-a163-4057-8790-f2111668ec672025-11-11WarningsExact identifier
application number: M020
Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEPILLOWTALKDERM LLC30e10a62-8430-649b-e063-6394a90a97eb2025-11-11WarningsExact identifier
application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTEDTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.279a5214-79b2-44e9-b003-378d0b9923952025-11-11WarningsExact identifier
application number: M020
Tinted Moisturizer SPF 46 Universal TintZINC OXIDE, OCTINOXATEDrmtlgy, LLC5304b568-f891-4094-9182-363ae7bcfbe42025-11-11WarningsExact identifier
application number: M020
C Lip Serum Mineral Broad Spectrum SPF 30SUNSCREENSimply Active Cosmetics323661a6-3602-1ce2-e063-6394a90a8e912025-11-10WarningsExact identifier
application number: M020
buttah Tinted Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEButtah Enterprises, LLC.43458152-0775-dd9c-e063-6394a90a61402025-11-10WarningsExact identifier
application number: M020
Aspen Glow 100% Mineral Broad Spectrum SPF 30 Powder Sunscreen 0.16 oz / 4.6 gZINC OXIDEAspen Glow Cosmetics, LLC142eda44-76e1-7960-e063-6394a90a9ad62025-11-10WarningsExact identifier
application number: M020
TriLipiderm Broad Spectrum SPF 30BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENETriLipid Research Institute, LLC617fc696-c2a1-4855-bafb-0454e64971012025-11-10WarningsExact identifier
application number: M020
TriLipiderm Protective DayHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENETriLipid Research Institute, LLC66726c2b-27e9-5dd1-e053-2991aa0a1ba72025-11-10WarningsExact 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