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 177 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9b0642-53ed-ec94-e063-6394a90aec3d2025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d977158-8b5d-66ac-e063-6294a90a4d5c2025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Kit SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0eae4b71-60be-9715-e063-6294a90af4632025-10-20WarningsExact identifier
application number: M020
Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum SunscreenZINC OXIDEAttitude DBA 9055-7588 Qubec Inc.9ed70230-980c-474c-9f72-a6be0f3551242025-10-20WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC419b8043-7921-ca77-e063-6394a90a99ba2025-10-20WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC419c8718-6b9e-3df7-e063-6294a90a1e3b2025-10-20WarningsExact identifier
application number: M020
Sonni SunDay SerumZINC OXIDESonni419d4ada-fe9b-b774-e063-6394a90a3d092025-10-20WarningsExact identifier
application number: M020
Lip Clear Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.66f84e56-4a5d-4b71-8bd3-79961e7bf4fe2025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus Strawberry Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.2cafc97f-4cd3-4755-b394-3802c28d4ed52025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus Tangerine Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.8a00194e-9e28-4257-82e5-59bc44f7897d2025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.c9318a8c-ba3b-4068-84df-110c9005ee1d2025-10-20WarningsExact identifier
application number: M020
Terez Honor Hydro SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEWYCREAM INC418d054b-436f-6aa3-e063-6294a90a0f562025-10-19WarningsExact identifier
application number: M020
Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECosmocos Co., Ltd41129799-85ed-2de2-e063-6394a90ab40c2025-10-17WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc5a67314-e5b2-4dd6-94e9-39c2f286c3462025-10-17WarningsExact identifier
application number: M020
LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREENZINC OXIDELion Pose Inc.0310407b-fb74-aa8b-e063-6294a90ad8412025-10-17WarningsExact identifier
application number: M020
Thrive Daily Defense Sunscreen Balm SPF30ZINC OXIDEThrive Natural Care, Inc1266bd05-1971-a7f0-e063-6394a90a089c2025-10-17WarningsExact identifier
application number: M020
AESOP Avail Body Sunscreen Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEEmeis Cosmetics Pty Ltd2cb40521-94ed-4e76-a4e2-de1c80155bd22025-10-17WarningsExact identifier
application number: M020
AESOP Avail Facial Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEmeis Cosmetics Pty Ltdbff60c2f-0cc6-493b-81a0-ed35e97461462025-10-17WarningsExact identifier
application number: M020
Mineral Lip Balm PineappleZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity667714f6-38bc-4c94-aacc-24b46e8e59fd2025-10-17WarningsExact identifier
application number: M020
ELEVEN BY VENUS WILLIAMS GAME SET MATCH BODYZINC OXIDEEco-Chic LLCdd2fe82e-31e1-1349-e053-2995a90aa4092025-10-16WarningsExact 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