CLE CCC GOLDEN MEDIUM DEEP- 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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69231-027_CCC Golden Medium Deep

Sunscreen

Titanium Dioxide 8.38%

Octinoxate 7%

Octisalate 3%

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, 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

image description

CLE CCC GOLDEN MEDIUM DEEP 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69231-027
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 DIOXIDE2.51454 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
AMILOXATE (UNII: 376KTP06K8)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
MICA (UNII: V8A1AW0880)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69231-027-021 in 1 PACKAGE12/03/2018
1NDC:69231-027-0130 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 finalpart35212/03/2018
Labeler - KW ABSC, INC. (079548604)
Registrant - KW ABSC, INC. (079548604)
Establishment
NameAddressID/FEIBusiness Operations
Cit Co., Ltd690081646manufacture(69231-027)

Revised: 12/2018
Document Id: 7c2408f5-6ee1-3d9c-e053-2a91aa0a1bae
Set id: b7a4847f-b84d-4f36-8787-104eccd838a0
Version: 1
Effective Time: 20181203
 
KW ABSC, INC.