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 149 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare37643884-f186-fb54-e063-6394a90a450f2025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8208b-7328-1891-e063-6294a90abdd92025-12-08Exact identifier
application number: M020
Protect Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8dedc-0575-9819-e063-6394a90afebf2025-12-08Exact identifier
application number: M020
Protect Mineral Stick ClearTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bfa392-dfec-bd8a-e063-6394a90acffa2025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b9d646-e049-6781-e063-6294a90ab1012025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen Non-TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be70d5-aefe-fd6f-e063-6394a90ac4362025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be17ce-c3a7-fd59-e063-6394a90ad11d2025-12-08Exact identifier
application number: M020
Protect Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35c044a6-90be-55f8-e063-6294a90aad482025-12-08Exact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUMOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ed877-2926-1fd9-e063-6394a90aa1532025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMELOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f1ad4c-af9a-c998-e063-6294a90a15db2025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TANOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f37a57-47ce-4175-e063-6394a90a92ee2025-12-08WarningsExact identifier
application number: M020
RECHARGE Protect BlurTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCc787e3b9-33b1-4c47-95bd-b14cf65589382025-12-08WarningsExact identifier
application number: M020
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
application number: M020
Inblair Elevate SPF15 MoisturizerINBLAIR ELEVATE SPF15 MOISTURIZERGuangzhou Fantesy Biotechnology Co.,Ltd4567d413-d8cc-677b-e063-6294a90a1a422025-12-07WarningsExact identifier
application number: M020
HANCHOBIT Radiant Pink Tone Up Sun CreamTITANIUM DIOXIDEHANCHOYEANBIOTEC Co.,Ltd.45685047-166d-8af5-e063-6294a90aa7be2025-12-07WarningsExact identifier
application number: M020
EELHOE Moisturiser Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.454004c9-07fa-64ad-e063-6394a90a0c8a2025-12-06WarningsExact identifier
application number: M020
OUHOE Daily Exposure Lightweight SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.454301b6-21a6-6153-e063-6294a90a13662025-12-06WarningsExact identifier
application number: M020
OUHOE Cotton Soft Sun StickTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4543a43e-acf7-6759-e063-6394a90a2f532025-12-06WarningsExact identifier
application number: M020
OUHOE Centella Daily SunTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4544f3a3-8c52-ea54-e063-6394a90a7a9c2025-12-06WarningsExact identifier
application number: M020
EELHOE All Day Light Sunscreen MistTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.45323ca3-c706-dcb5-e063-6394a90a96f72025-12-05WarningsExact 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