CLE CCC WARM MEDIUM- titanium dioxide, octinoxate, octisalate cream

CLE CCC Warm Medium by

Drug Labeling and Warnings

CLE CCC Warm Medium by is a Otc medication manufactured, distributed, or labeled by KW ABSC, INC., Cit Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 8.43%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 3.00%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

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

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.

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

Water, Cyclopentasiloxane, Iron Oxides (CI 77492), C12-15 Alkyl Benzoate, Butylene Glycol, Cyclohexasiloxane, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Mica (CI 77019), Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Diisostearyl Malate, Sodium Chloride, Iron Oxides (CI 77491), Polyester-1, Silica Dimethyl Silylate, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLE CCC WARM MEDIUM 
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69231-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 mg  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.9 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.52846 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
AMILOXATE (UNII: 376KTP06K8)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
MICA (UNII: V8A1AW0880)
NIACINAMIDE (UNII: 25X51I8RD4)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BEMOTRIZINOL (UNII: PWZ1720CBH)
CERESIN (UNII: Q1LS2UJO3A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
SORBITAN OLIVATE (UNII: MDL271E3GR)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CORN OIL (UNII: 8470G57WFM)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BERGAMOT OIL (UNII: 39W1PKE3JI)
ORANGE OIL (UNII: AKN3KSD11B)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
DIMETHICONE (UNII: 92RU3N3Y1O)
CANANGA OIL (UNII: 8YOY78GNNX)
ADENOSINE (UNII: K72T3FS567)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69231-025-02	1 in 1 PACKAGE	11/27/2018
1	NDC: 69231-025-01	30 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/27/2018

Labeler - KW ABSC, INC. (079548604)

Registrant - KW ABSC, INC. (079548604)

Establishment
Name	Address	ID/FEI	Business Operations
Cit Co., Ltd		690081646	manufacture(69231-025)