FDA.reportPublic FDA data

CLE CCC Neutral Fair

Product NDC
69231-033
11-digit product format
692310033
Labeler code
69231
Product ID
69231-033_29aa6ec9-9b5a-2b6b-e063-6294a90adf28
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
2022-10-24
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength
2.1; .9; 2.757 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 Fair
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2.1 mg/30mL
OCTISALATE.9 mg/30mL
TITANIUM DIOXIDE2.757 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
aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a2Available 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
69231-033-01CLE CCC Neutral Fair30 mL in 1 CONTAINERCREAM302
69231-033-02CLE CCC Neutral Fair1 in 1 PACKAGECREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69231-033CLE CCC NEUTRAL FAIR (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [KW ABSC, INC.]2Current NDC, Legacy NDC, 2 package rows20241222_aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a2.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 319 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosehip and Lemongrass Lip SPF 15ZINC OXIDEEminence Organic Skin Care4354171a-fd25-4c56-a67c-d48194ea98902023-11-30WarningsExact identifier
application number: M020
SOOTHE Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields9acbf663-15e4-4572-a267-56afa58a347b2023-11-30WarningsExact identifier
application number: M020
EltaMD UV Facial SPF30 PlusZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.8426b0a0-ecd6-4486-b2da-57a950b46dc52023-11-30WarningsExact identifier
application number: M020
Eminence Bright Skin Starter Set KitZINC OXIDEEminence Organic Skin Care6335dfaf-ebdf-4b7b-999e-fabeeaa907ed2023-11-29WarningsExact identifier
application number: M020
Cetaphil Healthy Radiance Whipped Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.69cdf676-34f6-4864-a2a6-9f547b0b45a02023-11-28WarningsExact identifier
application number: M020
Walgreens SPF 30 Premium Moisturizing Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0b24d878-065b-008c-e063-6394a90aa2cf2023-11-27WarningsExact identifier
application number: M020
UNBLEMISH Invisible Matte DefenseHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERodan & Fields9dfe7d50-f347-4671-9657-5e4fbe42b4412023-11-27WarningsExact identifier
application number: M020
SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aacafca-baf7-9a22-e063-6394a90a2ca92023-11-21WarningsExact identifier
application number: M020
SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aad5ced-f356-e294-e063-6394a90aa8d52023-11-21WarningsExact identifier
application number: M020
SPF 60 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aae69f1-66bf-a199-e063-6394a90a3d752023-11-21WarningsExact identifier
application number: M020
Walgreens SPF 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0aaeaf00-a438-8164-e063-6394a90a88362023-11-21WarningsExact identifier
application number: M020
Walgreens SPF 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0ab169df-a760-8978-e063-6394a90ac2f42023-11-21WarningsExact identifier
application number: M020
Sun X SPF 50 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMCoreTex Products, INCc0355990-b842-47cd-e053-2a95a90a7c822023-11-20WarningsExact identifier
application number: M020
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0a9b61ac-4f48-8399-e063-6394a90a43fe2023-11-20WarningsExact identifier
application number: M020
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a9c1b3f-656d-0d62-e063-6394a90a47312023-11-20WarningsExact identifier
application number: M020
Rite Aid Mineral Zinc Oxide Sunscreen Broad Spectrum SPF 50ZINC OXIDERite Aid0a9c37b1-6df3-37c6-e063-6394a90ac8c32023-11-20WarningsExact identifier
application number: M020
SPF 15 Lip and SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.0b385246-dc77-6874-e063-6394a90a59592023-11-20WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
application number: M020
Alba Botanica Maximum Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Inc02ba8b03-a1fc-608f-e063-6394a90a06a82023-11-16WarningsExact identifier
application number: M020
Alba Botanica Hawaiian SPF 50 CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Incf693699d-716c-af7f-e053-2a95a90af11a2023-11-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69231-033-016923100330130 mL in 1 CONTAINER30 mlHistorical
69231-033-02692310033021 CONTAINER in 1 PACKAGE (69231-033-02) / 30 mL in 1 CONTAINER (69231-033-01) 1 container2022-10-240000-00-00NoNoCurrent