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 336 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Exact Fit Longwearing Foundation Shade Tawny L3N1TITANIUM DIOXIDEAmway Corp706e1504-fad7-44fa-9030-f5b948e3e79b2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Cappuccino L5W1TITANIUM DIOXIDEAmway Corpb785af89-1134-4fc6-8388-c47c52d153e02023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Natural L2N2TITANIUM DIOXIDEAmway Corpdb24e10a-6957-4ce7-8b03-572caacc647a2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Caramel L5N1TITANIUM DIOXIDEAmway Corpe7d8616d-3e79-4b5e-b05b-fbb506c0203d2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Plush L3C1TITANIUM DIOXIDEAmway Corpff387c87-4ada-41c6-b62b-07a1432137702023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Walnut L6N1TITANIUM DIOXIDEAmway Corp48c0bb8b-2f89-465e-9ae6-98690a2f877c2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Buff L1W1OCTINOXATE, OXYBENZONEAmway Corp11a8cc16-33f1-43d1-9f35-aa0f6e70adf62023-10-22WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 ThinAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONECoreTex Products Inc980388b5-8314-3143-e053-2995a90a72882023-10-22WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 Multipack NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Productsf4ed9d7f-2d03-87d1-e053-2a95a90a3b4f2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Chablis L1C1OCTINOXATE, OXYBENZONEAmway Corp8cdf7dcf-c2fa-4e41-8d56-c4f6cebe0a902023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Mink L6W1OCTINOXATE, OXYBENZONEAmway Corp429044b1-f7b8-4d1e-8360-0feb380161dd2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Cream L1W2OCTINOXATE, OXYBENZONEAmway Corpe7e89303-f399-46c7-a029-c6d3d0a2dc4e2023-10-22WarningsExact identifier
application number: M020
Artistry Skin Nutrition BALANCING Matte DayAVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLCd4a87153-7ef0-4365-ad91-dced9b1d80552023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Light/MediumENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp830a748f-bb14-47f6-ab6f-48d8bd7063212023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition HYDRATING DayAVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLC06313228-7a79-48c5-8fd0-b210da6d037b2023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition RENEWING Reactivation Day SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLCbd4818b3-d5db-4812-96ec-1bd91aa1508b2023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Med/DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp20c432e2-4c63-485b-9dd5-2bc73b6f42852023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF50 Broad Spectrum Sunscreen - LightENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAccess Business Group LLC070f9538-4b36-471a-aa06-6669e9ecfdf02023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen MediumENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp40a82d20-b84b-4ae8-818d-1f503ceef5812023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition RENEWING Reactivation Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLC4a0af0e9-04da-4b5f-a57a-967bef7257892023-10-21WarningsExact 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