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
O414PZ4LPZInternal UNII lookup
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
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 25 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Frosted PetalZINC OXIDEOdacite52ba9423-8b9d-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - DawnZINC OXIDEIris and Romeo52bb700b-ff56-2286-e063-6394a90ac4582026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CamelliaZINC OXIDEIris and Romeo52bb52ec-2cd7-f8cc-e063-6294a90aa61b2026-05-26WarningsExact identifier
application number: M020
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDEBubble Beauty, Inc.d2eca90f-9463-4d2f-975d-02f2802ded3e2026-05-26WarningsExact identifier
application number: M020
Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30ZINC OXIDEPlexus Worldwide, LLC55c391fa-37c6-47a2-befd-12888eb5fc182026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - SuedeZINC OXIDEIris and Romeo52bb7505-a027-2533-e063-6294a90a25202026-05-26WarningsExact identifier
application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc9c909ae0-0117-4675-afc2-533d542f36592026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CarobZINC OXIDEIris and Romeo52bbe9da-37f8-b3ba-e063-6394a90a139e2026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CameoZINC OXIDEIris and Romeo52bc0174-872d-445b-e063-6294a90ab3292026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - IconicZINC OXIDEIris and Romeo52bbfdfe-dfc9-364f-e063-6294a90a646d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulip Dew BronzeZINC OXIDEBloomeffects52bc7f23-3594-3173-e063-6294a90a81ea2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulip DewZINC OXIDEBloomeffects0fcb1b45-c04d-310a-e063-6294a90ab56d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Mauve MomentZINC OXIDEBloomeffects52bd7522-81b5-6189-e063-6394a90a29b42026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil BarelyZINC OXIDEBloomeffects52bd8a43-a8c2-897e-e063-6394a90a9f3d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Fruit PunchZINC OXIDEBloomeffects52bdc0ec-ac5e-4a57-e063-6294a90a0b3b2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy PinkZINC OXIDEBloomeffects52bdc5cc-9742-4af6-e063-6294a90aba222026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - DaylightZINC OXIDENewAlley Innovations Inc52be1071-67cb-f2c0-e063-6294a90a368c2026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - HazyZINC OXIDENewAlley Innovations Inc52be3c9e-a791-5053-e063-6294a90a1b302026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - WhirlwindZINC OXIDENewAlley Innovations Inc52be633a-fc64-7456-e063-6294a90a8fc02026-05-26WarningsExact 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