FDA.reportPublic FDA data

CLE CCC Olive Medium Deep

Product NDC
69231-035
11-digit product format
692310035
Labeler code
69231
Product ID
69231-035_29aa3b8e-78f8-7098-e063-6294a90a01b4
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
2022-10-25
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength
2.1; .9; 2.561 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 Olive Medium Deep
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2.1 mg/30mL
OCTISALATE.9 mg/30mL
TITANIUM DIOXIDE2.561 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
be4434c0-cbdd-46cb-8015-4c7859e80d4aAvailable 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
69231-035-01CLE CCC Olive Medium Deep30 mL in 1 CONTAINERCREAM302
69231-035-02CLE CCC Olive Medium Deep1 in 1 PACKAGECREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69231-035CLE CCC OLIVE MEDIUM DEEP (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [KW ABSC, INC.]2Current NDC, Legacy NDC, 2 package rows20241222_be4434c0-cbdd-46cb-8015-4c7859e80d4a.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 192 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coco and Eve Sunny Honey Protect SPF 50 Highlighter Body SPF 50SUNSCREENSoleil Collective LLC3d4c90e7-0716-4d57-e063-6394a90a43fa2025-08-26WarningsExact identifier
application number: M020
Sun Bum 70 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c4433e2-d383-8326-e063-6294a90aaf982025-08-26WarningsExact identifier
application number: M020
Coco and Eve Sunny Honey Protect SPF 50 Coconut Milk Body SPF 50SUNSCREENSoleil Collective LLC3d4d1b94-b1ce-cf94-e063-6394a90a61ba2025-08-26WarningsExact identifier
application number: M020
naked TURTLE 30ZINC OXIDENAKED TURTLE SUNSCREEN LLC65f1570a-6156-40e6-a792-e0707607dc2f2025-08-26WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF 50ZINC OXIDEDelta Ecommerce LLC2d490531-af38-87d0-e063-6394a90acf492025-08-25WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC20d24c9d-9558-156d-e063-6294a90a2d1a2025-08-25WarningsExact identifier
application number: M020
Neutrogena Sport Face Oil Free Sunscreen Broad Spectrum SPF 70 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC413275e8-0011-471e-9539-ea95ed8384132025-08-25WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - BananaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d34d144-2515-d7fa-e063-6294a90abb3f2025-08-25WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 sunscreenAVOBENZONE 3.0%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 8.0%Florida Squeezed393b59aa-6d5a-4757-9f6d-59f7533aee862025-08-25WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d37ec29-8d15-c716-e063-6394a90ae7092025-08-25WarningsExact identifier
application number: M020
RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN ADOREZINC OXIDERms organics LLC3d386cc9-e097-dacf-e063-6294a90a8fe22025-08-25WarningsExact identifier
application number: M020
Baby Bum Mineral 50 Mineral Sunscreen Face StickZINC OXIDESun Bum, LLC3d3a0d5c-a366-22fc-e063-6394a90a308b2025-08-25WarningsExact identifier
application number: M020
BOB Kids Sun Balm SPF 40ZINC OXIDE 23%SPF Ventures, LLCefa5c501-273c-5e97-e053-2995a90a865b2025-08-24WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCe4a2e6e4-5c35-4178-b341-65644233b7b82025-08-22WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC57f91218-2477-4495-98e8-c512d823e1582025-08-22WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc358745d-b9c0-4a9e-9a83-caffa04ea2e52025-08-22WarningsExact identifier
application number: M020
Neutrogena Age Shield Face Oil Free Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC050c2997-3ec0-4515-8a67-709b07a5010f2025-08-22WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3cf3e27d-ab16-4f12-e063-6394a90a70e22025-08-22WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3cf42e31-4e11-9b6d-e063-6294a90aa7412025-08-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69231-035-016923100350130 mL in 1 CONTAINER30 mlHistorical
69231-035-02692310035021 CONTAINER in 1 PACKAGE (69231-035-02) / 30 mL in 1 CONTAINER (69231-035-01) 1 container2022-10-250000-00-00NoNoCurrent