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 240 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheglam Dew and Done Skin Tint with SPF 20 SandalwoodZINC OXIDEEVER FAME PTE. LTD.2ace641a-b440-d0b3-e063-6394a90a86322025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SepiaZINC OXIDEEVER FAME PTE. LTD.2acf4b3b-e82d-d512-e063-6294a90a3fef2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 TruffleZINC OXIDEEVER FAME PTE. LTD.2acf4b3b-e830-d512-e063-6294a90a3fef2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 WalnutZINC OXIDEEVER FAME PTE. LTD.2acf75d2-8ad7-1bd3-e063-6294a90ac0be2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 WheatZINC OXIDEEVER FAME PTE. LTD.2acf92a1-6d2a-5517-e063-6294a90a74882025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Warm VanillaZINC OXIDEEVER FAME PTE. LTD.2acf9020-c779-31c2-e063-6294a90a1ab52025-01-03WarningsExact identifier
application number: M020
Earths Daughter Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad009bc-29ce-0ba6-e063-6294a90a75802025-01-03WarningsExact identifier
application number: M020
Earths Daughter Bing Cherry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad07286-f8af-7a9f-e063-6394a90a6a242025-01-03WarningsExact identifier
application number: M020
Earths Daughter Vanilla Bean SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad0db95-a283-3c91-e063-6294a90ae5232025-01-03WarningsExact identifier
application number: M020
Earths Daughter Strawberry Breeze SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad129b7-4ecd-a967-e063-6294a90ad8c42025-01-03WarningsExact identifier
application number: M020
Earths Daughter Citrus Blast SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad18f4b-4251-be82-e063-6394a90acac52025-01-03WarningsExact identifier
application number: M020
Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad1bb50-869e-8122-e063-6294a90ac7242025-01-03WarningsExact identifier
application number: M020
Glow Baby Brightening Setting Mist SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPacifica Beauty, LLCf2f53cf9-3717-07ff-e053-2a95a90a03fb2025-01-03WarningsExact identifier
application number: M020
Future Youth Daily Turnaround Hydrating Moisturizer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEPacifica Beauty, LLC0324275f-13bc-e7b8-e063-6294a90a69022025-01-03WarningsExact identifier
application number: M020
Glow Baby Super Lit SPF 30ZINC OXIDEPacifica Beauty, LLCf3d3eee2-a5d9-113b-e053-2995a90a70572025-01-03WarningsExact identifier
application number: M020
Kind Tint SPF 30ZINC OXIDEPacifica Beauty, LLCf421cbf7-cfae-5eae-e053-2995a90ab35c2025-01-03WarningsExact identifier
application number: M020
Vegan Collagen Every Day SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEPacifica Beauty, LLCf449da32-5ade-2c78-e053-2a95a90a27a12025-01-03WarningsExact identifier
application number: M020
Members Mark SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESam's West Inc2b354ab6-f241-676f-e063-6394a90a58932025-01-03WarningsExact identifier
application number: M020
Vanilla Mint Lip BalmLIP BALMCasad Company Inc.3214bff3-e133-43ca-946d-f4c5dd0747602025-01-03WarningsExact identifier
application number: M020
Vanilla Lip BalmLIP BALMCasad Company Inc.d27398d3-98b0-4f70-997e-6ed02559594f2025-01-03WarningsExact 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