FDA.reportPublic FDA data

Stokoderm Sunscreen PURE

Product NDC
11084-032
11-digit product format
110840032
Labeler code
11084
Product ID
11084-032_f7f52005-0bcb-4da6-b4ca-55f339cba0b5
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octocrylene, Octisalate, and Homosalate
Dosage form
CREAM
Route
TOPICAL
Labeler
SC Johnson Professional USA, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-01
Substance
AVOBENZONE; OCTOCRYLENE; OCTISALATE; HOMOSALATE
Active strength
3; 10; 3; 5 g/100mL; g/100mL; g/100mL; g/100mL
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
Stokoderm Sunscreen PURE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
OCTOCRYLENE10 g/100mL
OCTISALATE3 g/100mL
HOMOSALATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ddf81e6-de78-4f2f-814b-c75eadcddb39Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-032-10Stokoderm Sunscreen PURE100 mL in 1 TUBECREAM1002
11084-032-27Stokoderm Sunscreen PURE1000 mL in 1 BOTTLE, PLASTICCREAM10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11084-032STOKODERM SUNSCREEN PURE (AVOBENZONE, OCTOCRYLENE, OCTISALATE, AND HOMOSALATE) CREAM [SC JOHNSON PROFESSIONAL USA, INC.]2Current NDC, Legacy NDC, 2 package rows20241225_3ddf81e6-de78-4f2f-814b-c75eadcddb39.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 328 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. C. Tuna Resurface Essential Day CreamHOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONEFarmasi US LLCb92ff1e9-9dc4-46cb-a99d-98ff15bffc792023-11-05WarningsExact identifier
application number: M020
Dr C Tuna Sun protector lip balm SPF 15HOMOSALATE, OCTINOXATEFarmasi US LLCddcd82b5-9ad2-2340-e053-2a95a90a4fc02023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to TanTITANIUM DIOXIDEFarmasi US LLCdeee5784-c68b-4cd7-acbf-f64391a01bfc2023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to MediumTITANIUM DIOXIDEFarmasi US LLCcef1a926-b7d4-47d6-957d-e3092e60970c2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance Brightening CreamOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCb55790f7-20f2-404e-9a0e-5e76c383bf752023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance Brightening Cream 22 SPFOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCde493e30-d10e-9def-e053-2995a90ae49a2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Face and Body SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLC141f9d22-deb7-4b6b-97b5-ee21898b96f72023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 06 DeepTITANIUM DIOXIDEFarmasi US LLC2f13a160-740f-4b09-8858-e438a9ba303e2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Bronzing Oil SPF 6OCTINOXATEFarmasi US LLC91b428cc-1c80-4d56-8450-790c66de41332023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 05 TanTITANIUM DIOXIDEFarmasi US LLC3f494921-844e-4010-ab0c-144c8dce8aca2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25TITANIUM DIOXIDEFarmasi US LLCf4fcfc78-9591-4a20-b9fb-88e1dc9b221d2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 02 Light to MediumTITANIUM DIOXIDEFarmasi US LLC0d913242-2e57-4ba7-a718-154af68480b22023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 03 MediumTITANIUM DIOXIDEFarmasi US LLC6ef986df-4044-4c32-8b64-f8110c9c95432023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 04 Medium to TanTITANIUM DIOXIDEFarmasi US LLCde24317f-2cf0-4125-bb17-c3d6b3c22e002023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 05 TanTITANIUM DIOXIDEFarmasi US LLC22842793-ae1f-4b71-8db9-34c06dc37daa2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 03 MediumTITANIUM DIOXIDEFarmasi US LLC9f203e7f-3bba-4f36-a35a-6d9466e390822023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 06 DeepTITANIUM DIOXIDEFarmasi US LLCc28afa3b-9a8d-4e19-bc6b-39cc8428c9f92023-11-05WarningsExact identifier
application number: M020
DR. C Tuna Sunscreen 30 SPF Broad Spectrum Face and bodyAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATETAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETIa71ee8e0-2d27-7ae6-e053-2a95a90aecd42023-11-05WarningsExact identifier
application number: M020
PHARMACA Natural Mineral Sunscreen SPF-50TITANIUM DIOXIDE, ZINC OXIDEPharmaca Integrative Pharmacy, Inc.51e6cd7a-5c9a-4666-9021-ade42eb064cd2023-11-05WarningsExact identifier
application number: M020
Dr.C.Tuna Sun Face Cream SPF50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETan Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret Anonim Sirketif668c078-61e6-2c81-e053-2a95a90a31002023-11-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11084-032-1011084003210100 mL in 1 TUBE (11084-032-10) 100 ml2021-02-010000-00-00NoNoCurrent
11084-032-27110840032271000 mL in 1 BOTTLE, PLASTIC (11084-032-27) 1000 ml2021-02-010000-00-00NoNoCurrent