FDA.reportPublic FDA data

CLE CCC Neutral Light

Product NDC
69231-028
11-digit product format
692310028
Labeler code
69231
Product ID
69231-028_29aa5688-3488-d1d1-e063-6294a90aa081
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Octinoxate, Octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
KW ABSC, INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-18
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength
2.1; .9; 2.6628 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 Neutral Light
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2.1 mg/30mL
OCTISALATE.9 mg/30mL
TITANIUM DIOXIDE2.6628 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
44cbb226-83ed-401b-baf8-ca8e4740dbefAvailable 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
69231-028-01CLE CCC Neutral Light30 mL in 1 CONTAINERCREAM302
69231-028-02CLE CCC Neutral Light1 in 1 PACKAGECREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69231-028CLE CCC NEUTRAL LIGHT (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [KW ABSC, INC.]2Current NDC, Legacy NDC, 2 package rows20241222_44cbb226-83ed-401b-baf8-ca8e4740dbef.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 153 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation66bb06fb-33d2-4b57-a65f-66bcd187c6272025-12-03WarningsExact identifier
application number: M020
PRO-TECT SUNSCREEN FOR PROFESSIONALSMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation374e172b-90e8-4fca-8934-dee3ed7b599d2025-12-03WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSELOCTINOXATE, ZINC OXIDEBEL STAR S A25b6cb46-6516-376a-e063-6394a90a44f62025-12-03WarningsExact identifier
application number: M020
LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR SA4510cd0d-40b8-f452-e063-6394a90a44e52025-12-03WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC45117885-c674-b58a-e063-6394a90af5f42025-12-03WarningsExact identifier
application number: M020
CANNON BALMOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.f70a0173-c8ba-da7c-e053-6294a90a67db2025-12-03WarningsExact identifier
application number: M020
CANNON BALM 140AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEDUKE CANNON SUPPLY CO.f70c8632-ed11-0cc3-e053-6394a90a77db2025-12-03WarningsExact identifier
application number: M020
Omega-Boost Sheer Mineral SunscreenMINERAL SUNSCREENTrilogy Natural Products Limited0405b7a6-6885-ed93-e063-6294a90a93862025-12-03WarningsExact identifier
application number: M020
Poolside Hot Head SPF 30 hair scalp sunscreen mistHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4517da75-c91a-1f93-e063-6394a90a65ac2025-12-03WarningsExact identifier
application number: M020
Poolside Tropic Touch SPF 30 Sunscreen Body spray.HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4517ef95-8ea1-3de6-e063-6394a90a2c792025-12-03WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Sunscreen oil mistHOMOSALATE 15%, OCTOCRYLENE 10%, OCTISALATE 5%, AVOBENZONE 3%Longway Technology(Guangzhou)Co.,Ltd.4517fd05-ea60-0492-e063-6294a90a28e92025-12-03WarningsExact identifier
application number: M020
e.l.f. All Set For Sun SPF 45 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.26f43446-e5ee-57a5-e063-6394a90a86612025-12-03WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC7678467a-9da3-1b51-e053-2991aa0a568f2025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENECARDINAL HEALTH, INC.b60cf360-7c8d-5da4-e053-2995a90a24c22025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b6107d22-a992-eaa1-e053-2995a90a29c22025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b623defb-4a9d-6fc5-e053-2995a90ae8462025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b62329d7-29e9-d111-e053-2a95a90aab062025-12-02WarningsExact identifier
application number: M020
Leader Ultra Sheer SPF 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECARDINAL HEALTH, INC.b5a467e0-a6ab-4136-8101-f22cc319de582025-12-02WarningsExact identifier
application number: M020
Leader General Protection SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.9544b046-055e-5886-e053-2a95a90ad09e2025-12-02WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44fe0844-cb74-7a04-e063-6294a90aca152025-12-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69231-028-016923100280130 mL in 1 CONTAINER30 mlHistorical
69231-028-02692310028021 CONTAINER in 1 PACKAGE (69231-028-02) / 30 mL in 1 CONTAINER (69231-028-01) 1 container2022-10-180000-00-00NoNoCurrent