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 257 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinka SPF 30 Clear SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Zinka, Incc054ac39-d03f-17c1-e053-2a95a90aa5ef2024-12-15WarningsExact identifier
application number: M020
QC SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%CDMAf82080b1-ef90-a027-e053-6294a90a19f22024-12-15WarningsExact identifier
application number: M020
QC SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%CDMAf80ceb05-0bd4-1355-e053-6294a90afb192024-12-15WarningsExact identifier
application number: M020
Lip Shine SPF35 SunscreenZINC OXIDEColorescience3a6506c4-1ba9-493a-a4c8-e5f9c60d221b2024-12-13WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM DEEPZINC OXIDECOSMAX USA, CORPORATION292165af-545d-db43-e063-6394a90ad1832024-12-13WarningsExact identifier
application number: M020
Tinted Lip Cream SPF 15ZINC OXIDECOSMAX USA, CORPORATION29227121-e579-8eea-e063-6394a90a302f2024-12-13WarningsExact identifier
application number: M020
BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONEBobbi Brown Professional Cosmetics Inc.03372376-ef03-943d-e063-6394a90a52ee2024-12-13WarningsExact identifier
application number: M020
WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEBobbi Brown Professional Cosmetics Inc.fbd04b66-738b-2762-e053-6394a90a8b722024-12-13WarningsExact identifier
application number: M020
Mentholatum Natural Ice CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company33f43f14-8e0b-41b1-8ad0-5723d2a7bf192024-12-13WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 8 SunscreenZINC OXIDEAbsolutely Naturala26217cf-22ab-4c39-980a-b73467e16b912024-12-13WarningsExact identifier
application number: M020
Calming Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienced681cdb5-307e-4a2a-8e1d-2b29131d48d02024-12-13WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 15 SunscreenZINC OXIDEAbsolutely Natural8084a3ee-fe31-4cb4-8d3c-e4035d29e5612024-12-13WarningsExact identifier
application number: M020
Mineral Corrector Palette SPF 20 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColorescienceab70122f-bd68-4781-841f-dc83284e14032024-12-13WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC0a0654cc-ad47-2167-e063-6294a90a52f42024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEBabo Botanicals, Inc.f8adda52-e909-1905-e053-6294a90a3c782024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Swim and Sport Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.f8b1ea3a-d62e-e00d-e053-6394a90a56892024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50ZINC OXIDEBabo Botanicals, Inc.f8b272f6-8726-de1d-e053-6294a90a7b1e2024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Super Shield Sport Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.e3ca7840-4882-d605-e053-2a95a90af6ab2024-12-12WarningsExact identifier
application number: M020
Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural GlowMINERAL SUNSCREENBabo Botanicals, Inc.ab39d9f0-d869-6f33-e053-2995a90a08d42024-12-12WarningsExact identifier
application number: M020
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs88dedeb8-963f-5849-e053-2995a90aab722024-12-12WarningsExact 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