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 150 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Srubs SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEITW Pro Brands06c1dc42-5a01-f898-e063-6394a90a1a1a2025-12-05WarningsExact identifier
application number: M020
OUHOE Tinted SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4540f542-248d-bcf5-e063-6294a90aabca2025-12-05WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS45c7703b-7ab4-2ef2-e063-6294a90a2b462025-12-05WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4645b051-ef5a-521e-e063-6294a90a24042025-12-05WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen bkidsZINC OXIDEKAS Direct LLC dba BabyGanicsf717cd89-194b-42e3-a079-24b2903deb292025-12-05WarningsExact identifier
application number: M020
Sugargirl Set SPF 30 sunscreen shimmer sunscreen mist for the faceHOMOSALATE , OCTOCRYLENE ,OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b662a-70ed-8ec5-e063-6294a90a005b2025-12-04WarningsExact identifier
application number: M020
Sugargirl SPF 30 sunscreen illuminating stick sunlightHOMOSALATE ,OCTOCRYLENE ,OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b71a9-2240-853f-e063-6394a90ac8f42025-12-04WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 SCENTED gel sunscreenHOMOSALATE,OCTOCRYLENE,OCTISALATE,OCTIONXATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b7229-67d1-8b0e-e063-6394a90ab71e2025-12-04WarningsExact identifier
application number: M020
Sugargirl SPF 30 sunscreen illuminating stick solarHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b7229-67d3-8b0e-e063-6394a90ab71e2025-12-04WarningsExact identifier
application number: M020
Poolside Sun Silk Body Cream SUNGLOW 05 FRAGRANCE Sunscreen SPF 30 body creamHOMOSALATE, OCTOCRYENE, OCTISALATE, QCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b86fa-6c1c-a708-e063-6394a90a47a92025-12-04WarningsExact identifier
application number: M020
Poolside Clear Intentions Invisible Face Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b902d-892d-15f1-e063-6294a90a30242025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451ba227-7973-1378-e063-6294a90ae8932025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451ba704-6fbd-d5a0-e063-6394a90a2fbc2025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Tropic TwistHOMOSALATE,OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bb62e-b603-7663-e063-6294a90a46db2025-12-04WarningsExact identifier
application number: M020
Prequel Lip Visor SPF 30 ROSEDUSTLIP 30 CLEARThe Center Brands, LLC33d5e1ad-ba7a-25f8-e063-6294a90aa38e2025-12-04WarningsExact identifier
application number: M020
Resting Beach Face SPF30 Anti-Pollution Sunscreen SerumBUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENEEveryday Group Limted54f8aca8-fbbc-498a-aaf8-aee716511dde2025-12-04WarningsExact identifier
application number: M020
Oh My Bod SPF50 Antioxidant Infused Dry Touch SunscreenBUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEEveryday Group Limted48e70326-ecf7-44c9-a4cc-2044bd6a64152025-12-04WarningsExact identifier
application number: M020
LIGHTSAVE TRIPLESOME SERUM TINTEDZINC OXIDEReve Skincare LLC35f5652f-3e6b-71c9-e063-6294a90a9e862025-12-04WarningsExact identifier
application number: M020
LIGHTSAVE TRIPLESOME SERUM IVORTYZINC OXIDEReve Skincare LLC35f4dd1b-c3d9-8408-e063-6394a90a79142025-12-04WarningsExact identifier
application number: M020
Activated Mineral Sunscreen TintedACTIVATED MINERAL SUNSCREEN TINTEDReve Skincare LLC312a32a7-d253-f10c-e063-6294a90a803a2025-12-04WarningsExact 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