DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY

Product NDC
66820-0500
11-digit product format
668200500
Labeler code
66820
Product ID
66820-0500_46a18880-2cb4-cf89-e063-6394a90afb0e
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
KOS� America, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-16
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE
Active strength
30; 74.945; 10 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
OCTINOXATE74.945 mg/mL
OCTISALATE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81352963-36ec-4099-af51-3498d89f3077Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66820-0500-1DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY45 mL in 1 CYLINDERCREAM452
66820-0500-1DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66820-0500DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY (AVOBENZONE, OCTINOXATE, OCTISALATE) CREAM [KOSE AMERICA, INC.]1Current NDC, 2 package rows20240517_81352963-36ec-4099-af51-3498d89f3077.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 41 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Light MediumZINC OXIDEZO Skin Health, Inc.4fabe9d0-27fe-230f-e063-6294a90a9ac02026-04-17WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Medium-TanZINC OXIDEZO Skin Health, Inc.4fac82b7-d685-2a0d-e063-6394a90aa7952026-04-17WarningsExact identifier
application number: M020
SALT WATER VANILLA SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENSaltair Body LLC4fae649d-f60e-0275-e063-6294a90a1ea52026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e64-2eab-1219-e063-6294a90a79a82026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd8a3-3d62-83ac-e063-6394a90a4afa2026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e2424f4-0011-42b0-e063-6394a90a780d2026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHTYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cfaea-b71f-2956-e063-6294a90a4f202026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUMYOUR NAME MINERAL SHEER TINTPML NYC, LLC316d1515-6092-a7d6-e063-6394a90ab8b22026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e70-6ec3-5711-e063-6394a90a38792026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20YOUR NAME MINERAL SHEER TINTPML NYC, LLC0e241343-db63-3f1c-e063-6394a90ab5382026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20YOUR NAME MINERAL SHEER TINTPML NYC, LLC316df5fe-0574-d59f-e063-6294a90af8b92026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316c5d69-46f4-7677-e063-6294a90a610f2026-04-17WarningsExact identifier
application number: M020
RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20PML NYC, LLC316d905f-232c-d8a2-e063-6394a90adbc92026-04-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream230 NPML NYC, LLC316ea01b-4bff-55be-e063-6394a90add942026-04-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream410 NPML NYC, LLC316e97bc-4b96-ba6e-e063-6294a90a76482026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c781d7-9d48-892f-e053-2a95a90aca862026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c757b4-6c92-18f0-e053-2a95a90a246d2026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c76a82-dc87-35e7-e053-2995a90ae3102026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7ac71-3f38-52b2-e053-2a95a90ab54e2026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7b929-7492-f072-e053-2995a90a1ca32026-04-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66820-0500-1668200500011 CYLINDER in 1 CARTON (66820-0500-1) / 45 mL in 1 CYLINDER1 cylinder2024-05-16NoNoCurrent