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 58 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2000DL-CL30TSPF30 BS TROPICALEpic Laboratories, LLC0286f94e-a2e8-b529-e063-6294a90ac08d2026-03-02WarningsExact identifier
application number: M020
2000DL-CL30VSPF30 BS ORIGINALEpic Laboratories, LLC1872eefd-d702-ac9f-e063-6294a90a24ef2026-03-02WarningsExact identifier
application number: M020
JAYSUING White Birch Moisturizing Sunscreen CreamTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.4c174691-cc32-b2e4-e063-6294a90a0f732026-03-02WarningsExact identifier
application number: M020
Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And PrimerZINC OXIDEKypris Beauty LLCa5d5f7bd-d7bf-4a5c-8530-b9d5d74754c32026-02-27WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association6307627a-94e2-47ea-8519-68975716dd6e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Associationa38e150e-2e50-4936-ae46-408f9cf82d152026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association87811c86-19d2-4179-8d22-2aeb4680ff572026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Associationd7215a32-00a9-4b70-8597-8ea91f546c1e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association9fccccd4-2d2e-4812-85b1-bbeb44ff04ea2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.be702a3b-1652-4468-803d-295100d3e3e22026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.644ec129-15c9-4ac1-8362-5b4c2e58ab9a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
SPF BeautySPF BEAUTYWalmart Inc.f06f26af-81d6-4603-b377-fd12430ec9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
SPF MoisturizerSPF MOISTURIZERWalmart Inc.41de3171-9ed3-45da-96fb-dfcf419122292026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Facial MoisturizerDAILY FACIAL MOISTURIZER SPF 15Walmart Inc.2cec9c90-2e64-f005-e063-6294a90a87532026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEWalmart Inc.309d881d-40e0-37bc-e063-6294a90a37692026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avbenzone, Homosalate, OctisalateAVBENZONE, HOMOSALATE, OCTISALATEWalmart Inc.d3d7a5d3-5c78-45c3-ba4b-7ac1a3b4526a2026-02-27WarningsExact identifier
application number: M020
MELAO Sunscreen StickETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE, AVOBENZONEGuangdong Aimu Biological Technology Co., Ltd4ba15c03-0409-918b-e063-6294a90ac6ee2026-02-26WarningsExact identifier
application number: M020
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
application number: M020
Olay Regenerist Whip Lightweight Moisturizer with Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4bbc0639-3a80-1c28-e063-6394a90a3c002026-02-26WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact 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