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 211 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLARINS - MULTI-INTENSIVE JOUR SUPER RESTORATIVE DAY BROAD SPECTRUM - SPF 15 - SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarins157cb8ca-1a36-41fb-be9e-b157b146dc4d2025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 50 SportAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutionse25e4f76-8311-491b-e053-2a95a90a4fc82025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e260b901-5918-48df-e053-2a95a90a68c32025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e25cf8e4-93cd-f5f6-e053-2995a90a45452025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 30 GallonAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e260c1bc-8b79-abc7-e053-2a95a90ae4d22025-05-06WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - Pink StrawberryZINC OXIDEKoco Life LLC347e665f-cb59-ab04-e063-6394a90ad0a62025-05-06WarningsExact identifier
application number: M020
Saucd Toasted Golden Tanning SPF 15 CaramelAVOBENZONE, OCTISALATE, HOMOSALATESAUCD GENERAL TRADING COMPANYe10d41cd-e03e-401c-9024-263350b3ec2a2025-05-05WarningsExact identifier
application number: M020
Visor Clear Body Mist Hydrating Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLCb2d7639c-cbfb-4127-8ee4-7355e0d021e12025-05-05WarningsExact identifier
application number: M020
Jacket Ultimate Performance Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBALSHI MD DERMACEUTICALSd4d82c41-01da-40af-a22c-d4d57af7a2f22025-05-05WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen Butter Stick SPF 50ZINC OXIDEElemental Herbs, Inc.114c6ac8-b133-cd16-e063-6294a90ac4f92025-05-05WarningsExact identifier
application number: M020
All Good kids mineral sunscreen butter stick SPF 50ZINC OXIDEElemental Herbs, Inc.feb94fd7-6727-6fb1-e053-6394a90a2af12025-05-05WarningsExact identifier
application number: M020
Vivier Sheer SPF 30 Mineral TintedTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.e12e3bcb-4c3d-41be-8e2b-12a817c8b3672025-05-05WarningsExact identifier
application number: M020
EVERY DAY MINERAL SUN SCREEN SPF 45ZINC OXIDEStream2Sea, LLC7ec4954f-7d60-405b-8bff-cb602fc44a4e2025-05-04WarningsExact identifier
application number: M020
ABIB QUICK AND AIRY SUNSTICK DUO SETHOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.34292261-4d05-e07d-e063-6294a90a47412025-05-02WarningsExact identifier
application number: M020
LION POSE UNGHOSTED TINTED MINERAL SPF 42 UVA UVB SUNSCREENZINC OXIDELion Pose Inc.341b90b4-82ae-e8c6-e063-6394a90aeefd2025-05-01WarningsExact identifier
application number: M020
LAPCOS DAILY SUNSCREEN SPF 50SUNSCREENLAP USA, INC.337c3528-5739-6b4a-e063-6294a90a3cb42025-05-01WarningsExact identifier
application number: M020
Hiya Kids SPF 40 Mineral SunscrenZINC OXIDEHiya Health Products LLC33119ec6-2cd8-8978-e063-6394a90afd972025-05-01WarningsExact identifier
application number: M020
EltaMD UV AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
application number: M020
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLCce93b371-26ab-4493-98e0-98234c3a9ba62025-05-01WarningsExact identifier
application number: M020
Winter Rescue KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.24356548-348d-2cd2-e063-6294a90ab3522025-04-29WarningsExact 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