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 215 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLCce93b371-26ab-4493-98e0-98234c3a9ba62025-05-01WarningsExact identifier
application number: M020
Winter Rescue KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.24356548-348d-2cd2-e063-6294a90ab3522025-04-29WarningsExact identifier
application number: M020
Prequel Lip Visor SPF 30 CLEARLIP 30 CLEARThe Center Brands, LLC33d5d1d4-c516-238c-e063-6294a90ac11c2025-04-28WarningsExact identifier
application number: M020
LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBEL STAR SA33db89ac-2653-78f5-e063-6394a90af03d2025-04-28WarningsExact identifier
application number: M020
LifeguardSUNSCREENSPHERE 8 INC32be4eb3-f106-182d-e063-6394a90aa4842025-04-28WarningsExact identifier
application number: M020
Practical Alchemy Purify and Protect DuoMICELLAR WATER WIPES AND ZINC OXIDEOver Here, LLC28514e58-59a6-094a-e063-6394a90a1c7d2025-04-28WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2fbf7f9d-dba7-48f9-b10e-63225e8f13992025-04-25WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd3380a271-1538-2e3a-e063-6294a90a90a22025-04-24WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd3380f1ac-0320-35f2-e063-6394a90a97eb2025-04-24WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDE 15%Yunqi Cosmetics (Shenzhen) Co., Ltd33813fe1-8496-d541-e063-6294a90a62542025-04-24WarningsExact identifier
application number: M020
Sunstation Sport Sunscreen SPF 30OCTISALATE, OCTOCRYLENE, ZINC OXIDEImpact Melanoma Incba78aa73-a25b-4a8e-99b2-9262bb9a7d272025-04-24WarningsExact identifier
application number: M020
Olay Age Defying Anti-Wrinkle Day Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company42819c8d-cc0a-4bee-95db-39a69ce7f6602025-04-24WarningsExact identifier
application number: M020
LBEL FOREVER MATTE LONGWEAR AND CONTROL FOUNDATION 72H SPF 15 CHAMPAGNE 170NOCTINOXATE, ZINC OXIDEBEL STAR S.A.338c2c66-497a-f7d1-e063-6294a90a77892025-04-24WarningsExact identifier
application number: M020
The Ordinary UV Filters SPF 45 SerumHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATEDeciem10cde253-26ee-b97d-e063-6394a90a83022025-04-23WarningsExact identifier
application number: M020
BareBack sunscreen SPF50 infused with Hyaluronic acid and vitamin CZINC OXIDEVeganicSKN3123aab6-0407-19e5-e063-6394a90a5bd82025-04-23WarningsExact identifier
application number: M020
Sephora Daily Sunscreen Cream Broad Spectrum SPF 30ZINC OXIDES+b49e043b-8164-421c-a02b-3dab0be1454d2025-04-22WarningsExact identifier
application number: M020
YAYA Organics SPF-50 Sports CreamZINC OXIDEYAYA ORGANICS L.L.C.9eabf1f8-698b-4fa8-98d3-3696c35b044c2025-04-22WarningsExact identifier
application number: M020
YAYA Organics SPF-50 Baby Kids Mineral SunscreenZINC OXIDEYAYA ORGANICS L.L.C.3275303d-a448-4fb4-bdce-6442823f89962025-04-22WarningsExact identifier
application number: M020
Oathology Inzincable Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, ZINC OXIDESKINOATH LLCd245dfca-9e32-4e71-9df8-58fff84ef6a92025-04-22WarningsExact identifier
application number: M020
Back9ine Skincare Pure Invisible Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBack 9ine Skincare, LLC974ede40-cfb5-4612-b168-5d42dd137f632025-04-22WarningsExact 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