CLE ESSENCE AIR CUSHION MEDIUM LIGHT- titanium dioxide, octinoxate, octisalate cream 
KW ABSC, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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69231-014_CLE Essence Air Cushion Medium Light

Titanium Dioxide 11.81%

Octinoxate 7.00%

Octisalate 3.00%

Sunscreen

Helps prevent sunburn

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

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

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

image description

CLE ESSENCE AIR CUSHION MEDIUM LIGHT 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69231-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.7715 g  in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.45 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69231-014-021 in 1 CARTON08/15/201810/29/2020
1NDC:69231-014-0115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/15/201810/29/2020
Labeler - KW ABSC, INC. (079548604)
Registrant - KW ABSC, INC. (079548604)
Establishment
NameAddressID/FEIBusiness Operations
Cit Co., Ltd.690081646manufacture(69231-014)

Revised: 10/2020
 
KW ABSC, INC.