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 72 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY48e8b7f5-6977-bfae-e063-6394a90a888b2026-01-21WarningsExact identifier
application number: M020
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Gold32725ca7-ec21-4643-bdc6-278fd647b95d2026-01-21WarningsExact identifier
application number: M020
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Golde6877f7a-3aaa-4096-bcb5-eae0aa2532e52026-01-21WarningsExact identifier
application number: M020
MINICELL UV SHIELD SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECELINA CO., LTD.48eff8fa-deec-a434-e063-6294a90aa8612026-01-21WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen Spf 30ZINC OXIDEDelta Ecommerce LLC47dbcf07-7e3a-e3de-e063-6294a90a2c212026-01-21WarningsExact identifier
application number: M020
sunscreenTITANIUM DIOXIDEGuangdong Zhoubang Biotechnology Co., Ltd48f13b1c-8104-881b-e063-6394a90a816d2026-01-21WarningsExact identifier
application number: M020
Sunscreen lip balmETHYLHEXYL SALICYLATEGuangdong Zhoubang Biotechnology Co., Ltd48f1ee5c-33d0-818c-e063-6294a90a1e592026-01-21WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen MotherCEILE SPF 30 PRIME PROTECT RADIATE MOTHERLE COSMETICS INC490db6ef-d7f2-446c-e063-6294a90af3032026-01-21WarningsExact identifier
application number: M020
DewyVita Zero Spot SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEBAREUNPLAN CO.,LTD.497c98c3-d809-52e0-e063-6294a90acca22026-01-21WarningsExact identifier
application number: M020
Mario Badescu The Moisture Magnet SPF 15OCTINOXATE, OXYBENZONE, AVOBENZONEBentley Laboratories LLC4c0b4733-96ea-4b1d-8a7b-13af66cc28d02026-01-21WarningsExact identifier
application number: M020
Sensitif Renewal Cream Daily Protection SPF 30 Broad Spectrum UVA UVB SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERV Skincare LLC86b46c9b-6573-439b-b38b-2d76d495df6d2026-01-20WarningsExact identifier
application number: M020
Perfectif Even Skin Tone Cream Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERV Skincare LLC1b8cf189-0d06-4e86-bd7b-b77a638f16702026-01-20WarningsExact identifier
application number: M020
Bella s Friends SPF50 SunscreenZINC OXIDEPANERGYTEKUSAINC48ce4ef7-e24a-4894-e063-6294a90a49c82026-01-20WarningsExact identifier
application number: M020
Christian Dior Invisible UV Fluid with Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Dior93a27f09-14e2-47a0-ac5f-4d3425e31ec92026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade TenZINC OXIDEClean Beauty For All, Inc (dba Saie)d00b978d-1682-4cde-ae5f-189e677136c42026-01-20WarningsExact identifier
application number: M020
Saie Sunvisor Broad Spectrum SPF 35 Sheer MoisturizerZINC OXIDEClean Beauty For All, Incb6bfd636-2f46-3fca-e053-2a95a90a05a62026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwoZINC OXIDEClean Beauty For All, Inc (dba Saie)19230647-29a3-d209-e063-6394a90aae362026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)8e2a2046-13e6-4a40-a0bc-65c979c59b932026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade EightZINC OXIDEClean Beauty For All, Inc (dba Saie)dbc4242a-3651-48be-bfc6-c595be5a2a152026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922f11d-10ce-82b4-e063-6394a90a66502026-01-20WarningsExact 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