CLE CCC WARM 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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Drug Facts

Titanium Dioxide 8.41%

Ethylhexyl Methoxycinnamate 7.00%

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

Water, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Cyclomethicone, Butylene Glycol, Isoamyl p-Methoxycinnamate, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Iron Oxides (CI 77492), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Diisostearyl Malate, Sodium Chloride, Mica (CI 77019), Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Sorbitan Olivate, Silica, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Polyester-1, Silica Dimethyl Silylate, Chlorphenesin, Dipropylene Glycol, Vegetable Oil, Dimethicone, Propylene Carbonate, 1,2-Hexanediol, Hydroxyacetophenone, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, 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

image description

CLE CCC WARM MEDIUM LIGHT 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69231-024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 mg  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.9 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5215 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
AMILOXATE (UNII: 376KTP06K8)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MICA (UNII: V8A1AW0880)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE OIL (UNII: AKN3KSD11B)  
CANANGA OIL (UNII: 8YOY78GNNX)  
ADENOSINE (UNII: K72T3FS567)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69231-024-021 in 1 PACKAGE11/27/2018
1NDC:69231-024-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/27/2018
Labeler - KW ABSC, INC. (079548604)
Registrant - KW ABSC, INC. (079548604)
Establishment
NameAddressID/FEIBusiness Operations
Cit Co., Ltd690081646manufacture(69231-024)

Revised: 11/2018
Document Id: 7bae89f3-eaf5-6777-e053-2a91aa0ab92f
Set id: fc90fb8a-44b3-47cd-882e-94ed324ed389
Version: 1
Effective Time: 20181127
 
KW ABSC, INC.