FDA.reportPublic FDA data

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 15 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bath and Body Works SPF CoconutAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.56078491-f7d6-97f7-e063-6394a90a6deb2026-07-07WarningsExact identifier
application number: M020
Natu Botanicals DAILY NATURAL SUNSCREEN SPF 35 Reef safe mineral sunscreen with non-nano zinc oxideZINC OXIDESurprise Enterprise LLC38cf4325-9720-f511-e063-6394a90ad6282026-07-07WarningsExact identifier
application number: M020
Sun Bum Road Tripper - Amazon - Coconut Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC560c0f35-2132-52a6-e063-6394a90a2d242026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 BonnieCIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIEDelicate Cosmetics Inc560d1d19-87a6-179b-e063-6294a90ada5e2026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 KellyCIELE LIP AND PROTECT LIPSTICK SPF 60 KELLYDelicate Cosmetics Inc560df34a-e6da-0792-e063-6394a90a7e712026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 LouLouCIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOUDelicate Cosmetics Inc560e37ae-87c0-39d2-e063-6394a90a2af42026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 CassetteCIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTEDelicate Cosmetics Inc560e4198-b07c-3d48-e063-6394a90a7be32026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 MargauxCIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUXDelicate Cosmetics Inc560e47d5-c881-438c-e063-6394a90a30912026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 SaddleCIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLEDelicate Cosmetics Inc560e5de5-1350-4046-e063-6394a90abffa2026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 PuzzleCIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLEDelicate Cosmetics Inc560e5558-8e46-7736-e063-6294a90acb052026-07-07WarningsExact identifier
application number: M020
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
application number: M020
Sunscreen SPF 50AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Products1d4be26a-4695-491c-85d1-86824e1cd0292026-07-06WarningsExact identifier
application number: M020
SPF 30 SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLC71856cb3-9386-4569-80e4-92826342e3862026-07-06WarningsExact identifier
application number: M020
Stay Ageless SunscreenBROAD SPECTRUM SPF 30TOXFAIRY, LLC55f7e07e-1689-6d38-e063-6294a90a91192026-07-06WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
application number: M020
RR SunHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEUndefined Inc87244432-2967-4145-89cd-11a7567083a32026-07-06WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.35af90d3-dfe1-30dc-e063-6294a90a10a52026-07-05WarningsExact identifier
application number: M020
MDP PEPTIDE 9 BIO SUN PROHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANESKINIDEA CO., LTD26db53cd-dd82-8790-e063-6394a90a92b12026-07-03WarningsExact identifier
application number: M020
SPF 50 plus SunscreenTITANIUM DIOXIDE AND ZINC OXIDETheravita LLCd8e276cc-0292-499d-9075-a83a2d3fafcc2026-07-02WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.5880b275-91fc-4589-a076-0e55409425d82026-07-02Warnings, Adverse reactionsExact 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