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 291 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanning Club Golden Glow Tanning Oil SPF-15AVOBENZONE, OCTISALATE, OCTOCRYLENETANNING CLUB, LLC748a9933-02a3-48c1-8636-8f0468f66a132024-07-17WarningsExact identifier
application number: M020
Tan De Soleil Orange Tanning Balm SPF 6HOMOSALATE, OCTISALATETANNING CLUB, LLC5343f359-6074-467c-99bb-f08a7ca2df412024-07-17WarningsExact identifier
application number: M020
Tanning Club Tanning SPF-8AVOBENZONE, OCTOCRYLENETANNING CLUB, LLCbbf9d61e-f2e6-4fde-baad-c412091c60b62024-07-17WarningsExact identifier
application number: M020
Mackenzies SPF 40 Ocean Safe SunscreenZINC OXIDENaturally Uncommon LLC1c314b70-45a7-1bd1-e063-6294a90a0d6b2024-07-17WarningsExact identifier
application number: M020
Bitchstix Eucalyptus Mint SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d764eb8-a0a7-d034-e063-6394a90aef242024-07-17WarningsExact identifier
application number: M020
Bitchstix Acai Berry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d765c28-f9da-15b6-e063-6394a90a057f2024-07-17WarningsExact identifier
application number: M020
Bitchstix Banana Kiwi SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76e972-4fc1-9438-e063-6294a90a58452024-07-17WarningsExact identifier
application number: M020
Bitchstix Pineapple Twist SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7699f4-3088-9436-e063-6294a90ab8522024-07-17WarningsExact identifier
application number: M020
Bitchstix Black Cherry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76824a-eac4-2d1f-e063-6294a90a8e662024-07-17WarningsExact identifier
application number: M020
Bitchstix Classic Coconut SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76aed7-308b-5cc5-e063-6394a90a45432024-07-17WarningsExact identifier
application number: M020
Bitchstix Pink Watermelon SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76e9b7-95af-6015-e063-6294a90a6f192024-07-17WarningsExact identifier
application number: M020
Bitchstix Vanilla Creme SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7713a9-de97-f0ff-e063-6294a90a80032024-07-17WarningsExact identifier
application number: M020
Bitchstix Grapefruit SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7723c7-984a-a789-e063-6394a90abdc42024-07-17WarningsExact identifier
application number: M020
Bitchstix Matcha and Aloe SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d771406-7c59-6052-e063-6394a90a01e62024-07-17WarningsExact identifier
application number: M020
Bitchstix Lemon Twist SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d770a10-a9fa-94c4-e063-6294a90a137a2024-07-17WarningsExact identifier
application number: M020
Bitchstix Mango SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77866e-64f2-86d6-e063-6394a90a12922024-07-17WarningsExact identifier
application number: M020
Bitchstix Peachy Peach SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77c31e-c606-74b7-e063-6294a90a2cee2024-07-17WarningsExact identifier
application number: M020
Bitchstix Pink Lemon SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77d785-56eb-e865-e063-6394a90acd012024-07-17WarningsExact identifier
application number: M020
Bitchstix Pomegranate SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77e9c3-cffd-0bb6-e063-6294a90aacd12024-07-17WarningsExact identifier
application number: M020
Bitchstix Strawberry Dragon Fruit SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77f460-e7be-30fe-e063-6394a90a8f1e2024-07-17WarningsExact 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