FDA.reportPublic FDA data

CLE CCC Warm Deep

Product NDC
69231-032
11-digit product format
692310032
Labeler code
69231
Product ID
69231-032_29aa682e-f2dd-b8d4-e063-6394a90a0982
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Octinoxate, Octisalate, Avobenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
KW ABSC, INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-08
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; AVOBENZONE
Active strength
2.1; .6; .51; .156 mg/30mL; mg/30mL; mg/30mL; mg/30mL
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
CLE CCC Warm Deep
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2.1 mg/30mL
OCTISALATE.6 mg/30mL
TITANIUM DIOXIDE.51 mg/30mL
AVOBENZONE.156 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
15FIX9V2JPInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ab3e360-8104-4439-93fb-e11bc4a77558Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69231-032-01CLE CCC Warm Deep30 mL in 1 CONTAINERCREAM302
69231-032-02CLE CCC Warm Deep1 in 1 PACKAGECREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69231-032CLE CCC WARM DEEP (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [KW ABSC, INC.]2Current NDC, Legacy NDC, 2 package rows20241222_6ab3e360-8104-4439-93fb-e11bc4a77558.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 156 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Sensitive natural Mineral Sunscreen Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE4495a302-51b9-3bf2-e063-6294a90a7e4f2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen Sprayer SPF 50 Watermelon and cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aa1349-e3f1-9b80-e063-6294a90a0fbd2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aaa3c8-ccc4-ae93-e063-6394a90aedc52025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aba591-04da-fe09-e063-6394a90a912a2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aba6d7-7989-0637-e063-6394a90a6c8f2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Tropical cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44abca13-8ba9-8925-e063-6294a90accb52025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sensitive natural baby Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44abdfe1-ea6b-a158-e063-6294a90a3eb82025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Watermelon and cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aca1d5-6e0a-def3-e063-6294a90aca262025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Sun kissed vanillaZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aca181-2a90-20a6-e063-6394a90aff472025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen Sprayer SPF 50 Sun kissed vanillaZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aa529b-2077-3660-e063-6394a90aa4052025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ad65f0-ec1d-1638-e063-6294a90a22442025-11-28WarningsExact identifier
application number: M020
HOEGOA Hair Scalp Sunscreen MineralTITANIUM DIOXIDEGuangzhou Hoegoa Biotechnology Co., Ltd.44b37930-b302-338c-e063-6394a90a5f7f2025-11-28WarningsExact identifier
application number: M020
OCEAURA Glitter SunscreenTITANIUM DIOXIDEGuangzhou Oceaura Biotechnology Co., Ltd.44b47284-57cd-2e61-e063-6394a90a50722025-11-28WarningsExact identifier
application number: M020
OUHOE Moisturizing And Translucent SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.34e8e4a6-2782-9a3d-e063-6394a90a84c22025-11-27WarningsExact identifier
application number: M020
OUHOE Protection SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4272dcef-eda5-1013-e063-6294a90adf382025-11-27WarningsExact identifier
application number: M020
OUHOE SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.42fcc9ed-083c-6582-e063-6394a90ae9e62025-11-27WarningsExact identifier
application number: M020
EELHOE Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305cb87e-450f-840a-e063-6294a90a883f2025-11-27WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.349a3d72-9969-855d-e063-6394a90a281c2025-11-27WarningsExact identifier
application number: M020
EELHOE Cica Cooling Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305c13af-0843-f478-e063-6394a90a42de2025-11-27WarningsExact identifier
application number: M020
EELHOE Quick Sun Stick Protection BarTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.3578c958-a457-402b-e063-6394a90a73422025-11-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69231-032-016923100320130 mL in 1 CONTAINER30 mlHistorical
69231-032-02692310032021 CONTAINER in 1 PACKAGE (69231-032-02) / 30 mL in 1 CONTAINER (69231-032-01) 1 container2022-11-080000-00-00NoNoCurrent