CLE ESSENCE AIR CUSHION MEDIUM DEEP- titanium dioxide, octinoxate, octisalate cream

CLE Essence Air Cushion Medium Deep by

Drug Labeling and Warnings

CLE Essence Air Cushion Medium Deep 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 9.58%

Octinoxate 7.00%

Octisalate 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.
Stop using and ask a doctor if rash occurs.

When using this product, keep out of eyes. Rinse with water to remove.

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, C12-15 Alkyl Benzoate, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Diphenylsiloxy Phenyl Trimethicone, Butylene Glycol, Isoamyl p-Methoxycinnamate, Niacinamide, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Alcohol Denat., Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sodium Chloride, Iron Oxides (CI 77492), Trimethylsiloxysilicate, Synthetic Beeswax, Disteardimonium Hectorite, Iron Oxides (CI 77491), Dimethicone, Chlorphenesin, Trihydroxystearin, Dipropylene Glycol, 1,2-Hexanediol, Hydroxyacetophenone, Vegetable Oil, Propylene Carbonate, Iron Oxides (CI 77499), Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Adenosine, Cananga Odorata Flower Oil, Triethoxycaprylylsilane, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Bambusa Vulgaris Leaf/Stem Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Cocos Nucifera (Coconut) Oil, Hydrolyzed Hyaluronic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLE ESSENCE AIR CUSHION MEDIUM DEEP 
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69231-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.437 g  in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g  in 15 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.45 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
AMILOXATE (UNII: 376KTP06K8)
NIACINAMIDE (UNII: 25X51I8RD4)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
BEMOTRIZINOL (UNII: PWZ1720CBH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CORN OIL (UNII: 8470G57WFM)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BERGAMOT OIL (UNII: 39W1PKE3JI)
ORANGE OIL (UNII: AKN3KSD11B)
ADENOSINE (UNII: K72T3FS567)
CANANGA OIL (UNII: 8YOY78GNNX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69231-016-02	1 in 1 CARTON	08/15/2018
1	NDC: 69231-016-01	15 g 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	08/15/2018

Labeler - KW ABSC, INC. (079548604)

Registrant - KW ABSC, INC. (079548604)

Establishment
Name	Address	ID/FEI	Business Operations
Cit Co., Ltd.		690081646	manufacture(69231-016)