FDA.reportPublic FDA data

CLE CCC Golden Medium

Product NDC
69231-034
11-digit product format
692310034
Labeler code
69231
Product ID
69231-034_29aa4543-0fcc-c9f5-e063-6294a90a3acc
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; 2.751 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 Golden Medium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2.1 mg/30mL
OCTISALATE.9 mg/30mL
TITANIUM DIOXIDE2.751 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
de50e956-a014-4147-922b-63c95fa6f86bAvailable 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
69231-034-01CLE CCC Golden Medium30 mL in 1 CONTAINERCREAM302
69231-034-02CLE CCC Golden Medium1 in 1 PACKAGECREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69231-034CLE CCC GOLDEN MEDIUM (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [KW ABSC, INC.]2Current NDC, Legacy NDC, 2 package rows20241222_de50e956-a014-4147-922b-63c95fa6f86b.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 267 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf5a006d1-e957-4063-9b45-2874a1445a332024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6943a531-c4e7-4e98-9970-3a30b9681b7b2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora74102d3-b535-4419-8e21-e961980e489d2024-11-11WarningsExact identifier
application number: M020
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50TITANIUM DIOXIDE AND ZINC OXIDEDARPHIN DIST.91277514-4db0-4b40-b95a-3530cac711df2024-11-11WarningsExact identifier
application number: M020
DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAveda Corporationdfa84bcc-a9b4-426d-8733-35f58c40e94d2024-11-11WarningsExact identifier
application number: M020
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYfef47045-1d3c-4f08-acec-e96abefbc2612024-11-08WarningsExact identifier
application number: M020
MeleNO SHADE SUNSCREEN OILCONOPCO Inc. d/b/a Unileverbd969eab-1da6-76a8-e053-2995a90a5c472024-11-07WarningsExact identifier
application number: M020
Vaseline Men plus Care Hydrate FaceAGING CHEST AND NECK RESCUE TREATMENT CREAMCONOPCO Inc. d/b/a Unileverbd0a9f3c-eaa9-47d0-e053-2995a90ab6172024-11-07WarningsExact identifier
application number: M020
VaselineAGING CHEST AND NECK RESCUE TREATMENT CREAMCONOPCO Inc. d/b/a Unileverbd965bbc-c9d1-c8da-e053-2995a90a22582024-11-07WarningsExact identifier
application number: M020
St. Ives Men plus Care Hydrate FaceSOLUTIONS CLEAR SKIN MOISTURIZER SUNSCREENCONOPCO Inc. d/b/a Unileverbcbaaa15-479d-b130-e053-2a95a90afa3b2024-11-07WarningsExact identifier
application number: M020
Dove Men plus Care Hydrate FaceAVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENECONOPCO Inc. d/b/a Unilever5c28d679-3f92-49e3-8bef-de1c3870f0092024-11-07WarningsExact identifier
application number: M020
Mele Men plus Care Hydrate FaceNO SHADE SUNSCREEN OILCONOPCO Inc. d/b/a Unileverbb2921bc-8892-1db2-e053-2995a90ae28c2024-11-07WarningsExact identifier
application number: M020
PondsREJUVENESS ANTI-WRINKLE DAILY MOISTURIZER WITH SUNSCREEN SPF 30CONOPCO Inc. d/b/a Unilever736ee790-99f7-686c-e053-2a91aa0ad16e2024-11-07WarningsExact identifier
application number: M020
Mele Men plus Care Hydrate FaceDEW THE MOST SHEER MOISTURIZER SUNSCREENCONOPCO Inc. d/b/a Unileverbb27185b-5732-a648-e053-2a95a90aa9302024-11-07WarningsExact identifier
application number: M020
PondsCLARANT B3 EVEN SKIN TONE DAILY MOISTURIZER WITH SUNSCREEN SPF 30CONOPCO Inc. d/b/a Unilever736ee790-9a15-686c-e053-2a91aa0ad16e2024-11-07WarningsExact identifier
application number: M020
Byoma Ultralight Face Fluid SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBYOMA LIMITED2657bca4-bdc7-d959-e063-6394a90a2aa12024-11-07WarningsExact identifier
application number: M020
Byoma Ultralight Face Fluid SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBYOMA LIMITED2658df86-8cbb-83dd-e063-6394a90ac4e82024-11-07WarningsExact identifier
application number: M020
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY547388c6-378b-488b-89d1-c77ebc5d2ed82024-11-07WarningsExact identifier
application number: M020
SPF30 SUMMER BLEND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY9641b71a-81f2-4157-801b-162188392a912024-11-07WarningsExact identifier
application number: M020
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd79cf2d9-4923-452a-bb44-67e059ee37ee2024-11-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69231-034-016923100340130 mL in 1 CONTAINER30 mlHistorical
69231-034-02692310034021 CONTAINER in 1 PACKAGE (69231-034-02) / 30 mL in 1 CONTAINER (69231-034-01) 1 container2022-10-250000-00-00NoNoCurrent