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 322 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOU-V SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEYouV, LLC290cd617-aa90-4f10-8a1d-d8954b9270042023-11-11WarningsExact identifier
application number: M020
BEAST SPIT and POLISH FACE SPF-20OCTOCRYLENE, OCTISALATE, AVOBENZONESmall Batch Beauty, LLC27e5244b-4b69-4dec-9dd5-ba8b71b171b22023-11-11WarningsExact identifier
application number: M020
SEVEN MINERALS Skin Friendly SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESeven Minerals NA LLCbd60cf89-e0e9-48ad-b174-1ecf72557d9c2023-11-11WarningsExact identifier
application number: M020
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.743f3d23-0f5c-4724-9f69-411c109506e12023-11-11WarningsExact identifier
application number: M020
SEVEN MINERALS Skin Friendly SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeven Minerals NA LLC6d6b5b2a-210a-4606-9cdb-f6eec10f37e82023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Baby Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCac66ad82-a01f-4e44-92a7-b5ab5bd309222023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Daily Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLC1745dc35-648e-4315-a285-c99ebeef4f6a2023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Face Factor Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCedc2c1e7-e1a8-4b49-96df-8a94eb6a242a2023-11-11WarningsExact identifier
application number: M020
ONCODERM Rx Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEOncoderm, LLC9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae2023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO. SPF 50 SPORTOCTOCRYLENE, ZINC OXIDE, OCTISALATEThe Seaweed Bath Co.f01516bf-8aed-4402-a3f9-ef11c54d46b32023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO. SPF-30OCTOCRYLENE, ZINC OXIDE, OCTISALATEThe Seaweed Bath Co.4df55434-fb9a-442d-82cf-16a4957f0a2a2023-11-11WarningsExact identifier
application number: M020
PROJECT REEF Mineral Sunscreen SPF-30ZINC OXIDEProject Reef LLCb7de9ec2-6db1-4c89-b734-15c4bd5c32512023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO Cooling Mist SPF-60 SportHOMOSALATE, OCTISALATE, ZINC OXIDEThe Seaweed Bath Co.98ccbb70-6e1a-4e92-a095-cbc4be12fcbf2023-11-11WarningsExact identifier
application number: M020
PROJECT REEF Mineral Sunscreen SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC87b9170c-956e-4aa2-9416-da00cca81b582023-11-11WarningsExact identifier
application number: M020
YOUTH CORRIDOR Soothe and Defend SPF-30OCTOCRYLENE, OCTISALATE, ZINC OXIDEYouth Corridor5c0873ff-8e76-48de-919d-f69794c4bd372023-11-11WarningsExact identifier
application number: M020
ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDEZITSTICKA, Inc32164318-7a7e-40b2-99da-8246c99fdbd32023-11-11WarningsExact identifier
application number: M020
SUNNY Q Broad Spectrum SPF-30ZINC OXIDESunny Q Sunscreen LLC593870fa-425c-401c-ac26-f63f4ce0298f2023-11-11WarningsExact identifier
application number: M020
BRICKELL Daily Defense Face Moisturizer SPF-20OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC44806b83-9220-4d34-806d-20cf0a47186e2023-11-11WarningsExact identifier
application number: M020
BRICKELL Element Defense Moisturizer SPF-45OCTOCRYLENE, OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC94be278a-3773-469b-8e40-3242d1072a3d2023-11-11WarningsExact identifier
application number: M020
I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEThirty7 LLC6ff00b6e-1cc7-4cc4-842b-4e379f75e4542023-11-11WarningsExact 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