CLE CCC Golden Medium Deep

Manufacturer
KW ABSC, INC. | Cit Co., Ltd
Effective date
2018-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:30

Label at a glance#

ProductCLE CCC Golden Medium Deep
Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Sunscreen

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.38%

Octinoxate 7%

Octisalate 3%

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months

WARNINGS SECTION

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT SECTION

Water, Cyclomethicone, Iron Oxides (CI 77492), C12-15 Alkyl Benzoate, Butylene Glycol, Cyclopentasiloxane, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Mica (CI 77019), Niacinamide, Dicaprylyl Carbonate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cyclohexasiloxane, Ceresin, Iron Oxides (CI 77491), Diisostearyl Malate, Sodium Chloride, Polyester-1, Silica, Silica Dimethyl Silylate, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Sorbitan Olivate, Iron Oxides (CI 77499), Vegetable Oil, Chlorphenesin, Dipropylene Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, 1,2-Hexanediol, Propylene Carbonate, Hydroxyacetophenone, Dimethicone, Cananga Odorata Flower Oil, Adenosine, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Bambusa Vulgaris Leaf/Stem Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Hydrolyzed Hyaluronic Acid, Tocopherol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
69231-027-01CLE CCC Golden Medium Deep30 mL in 1 CONTAINERCREAM301
69231-027-02CLE CCC Golden Medium Deep1 in 1 PACKAGECREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69231-027CLE CCC GOLDEN MEDIUM DEEP (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [KW ABSC, INC.]1Current NDC, Legacy NDC, 2 package rows20181204_b7a4847f-b84d-4f36-8787-104eccd838a0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69231-02769231-027-01, 69231-027-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLE CCC Golden Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b7a4847f-b84d-4f36-8787-104eccd838a02018-12-03WarningsExact identifier
ndc (package): 69231-027-02
ndc (package): 69231-027-01
ndc (product): 69231-027
ndc11 (package): 69231002701
ndc11 (package): 69231002702
spl id: 7c2408f5-6ee1-3d9c-e053-2a91aa0a1bae
spl set id: b7a4847f-b84d-4f36-8787-104eccd838a0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.