CLE CCC NEUTRAL MEDIUM- 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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69231-030_CLE CCC Neutral Medium

Titanium Dioxide 9.30%

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, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Cyclohexasiloxane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Iron Oxides (CI 77492), Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Diisostearyl Malate, Sodium Chloride, Mica (CI 77019), Iron Oxides (CI 77491), Disteardimonium Hectorite, Iron Oxides (CI 77499), Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Polyester-1, Silica Dimethyl Silylate, Chlorphenesin, Dipropylene Glycol, Dimethicone, Vegetable Oil, 1,2-Hexanediol, Propylene Carbonate, Hydroxyacetophenone, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Phenyl Trimethicone, Dimethicone Crosspolymer, Adenosine, Cananga Odorata Flower Oil, 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, Glycerin, Melissa Officinalis Leaf Extract, Chrysanthemum Indicum Flower Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aspalathus Linearis Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Jasminum Officinale (Jasmine) Flower Water, Veronica Officinalis Extract, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Alcohol, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Tocopherol

image description

CLE CCC NEUTRAL MEDIUM 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69231-030
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 DIOXIDE2.7888 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
AMILOXATE (UNII: 376KTP06K8)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
CERESIN (UNII: Q1LS2UJO3A)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
POLYESTER-10 (UNII: 212N9O2MMZ)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CORN OIL (UNII: 8470G57WFM)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE OIL (UNII: AKN3KSD11B)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
ADENOSINE (UNII: K72T3FS567)  
CANANGA OIL (UNII: 8YOY78GNNX)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69231-030-021 in 1 PACKAGE10/18/2022
1NDC:69231-030-0130 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 finalpart35210/18/2022
Labeler - KW ABSC, INC. (079548604)
Registrant - KW ABSC, INC. (079548604)
Establishment
NameAddressID/FEIBusiness Operations
Cit Co., Ltd690081646manufacture(69231-030)

Revised: 10/2022
Document Id: eb58fa24-2877-ba75-e053-2a95a90a85a6
Set id: a297ff64-678c-4936-8384-022606a2f33c
Version: 1
Effective Time: 20221018
 
KW ABSC, INC.