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 346 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antioxidant Sunscreen SPF 40OCTINOXATE AND ZINC OXIDETopiderm, Inc.2686378c-8827-47fb-b3ed-07438bd4e9e22019-11-13WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool VanillaOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASd701c221-9f68-47ff-b766-2f4f1998649f2019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 AmberOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS7f5e6872-4d26-410e-8afe-16a016f9a3992019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm IvoryOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS1124ba7d-a328-409b-8c88-e74bb3e501f52019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 HoneyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS9c407dc7-fcde-4660-9a06-57bd8a6b867d2019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 ChestnutOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASf07e8bb2-30ae-4337-ad60-84f55f2ff3542019-10-08WarningsExact identifier
application number: M020
Thinkbaby Sunscreen SPF 30ZINC OXIDEthinkOperations,LLC86249f33-e635-4455-a039-3a25aa3478df2019-03-25WarningsExact identifier
application number: M020
Sun Defense Mineral Sunscreen SPF 30 FaceZINC OXIDEderma e635ae850-7ce4-4cb7-bdaf-bec00904ca022018-11-12WarningsExact identifier
application number: M020
Thinksport Sunscreen SPF 30ZINC OXIDEthinkOperations,LLCa8591509-65f7-4e62-8642-4b8e63f1fef32018-11-08WarningsExact identifier
application number: M020
Essential Defense Everyday Clear Broad Spectrum SPF 47 SunscreenZINC OXIDE AND OCTINOXATEAllergan, Inc.bc872876-20e7-40cb-b79d-68998883681a2016-03-01WarningsExact identifier
application number: M020
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.6a996e03-907f-4e6a-b232-0892b86956b02015-08-21WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD.30468afc-9616-4765-b046-12e97a0a78272010-12-20WarningsExact 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