CLE CCC NEUTRAL FAIR- 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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69231-033_CLE CCC Neutral Fair

Titanium Dioxide 9.19%

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, Butylene Glycol, Isoamyl p-Methoxycinnamate, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Diisostearyl Malate, Sodium Chloride, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, CI 77492, Mica, Dipropylene Glycol, Hydroxyacetophenone, Dimethicone, Vegetable Oil, Chlorphenesin, Propylene Carbonate, CI 77491, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Polyester-1, Silica Dimethyl Silylate, CI 77499, Phenyl Trimethicone, Dimethicone Crosspolymer, Adenosine, Cananga Odorata Flower Oil, Melissa Officinalis Leaf Extract, Chrysanthemum Indicum Flower Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aspalathus Linearis Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Jasminum Officinale (Jasmine) Flower Water, Natto Gum, Saussurea Involucrata Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Tocopheryl Acetate, Hydrolyzed Hyaluronic Acid, Glycerin, Veronica Officinalis Extract, Dipotassium Glycyrrhizate, 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 FAIR 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69231-033
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 DIOXIDE2.757 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
AMILOXATE (UNII: 376KTP06K8)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
CERESIN (UNII: Q1LS2UJO3A)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MICA (UNII: V8A1AW0880)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CORN OIL (UNII: 8470G57WFM)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE OIL (UNII: AKN3KSD11B)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
ADENOSINE (UNII: K72T3FS567)  
YLANG-YLANG OIL (UNII: 8YOY78GNNX)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ROSEMARY (UNII: IJ67X351P9)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
THYME (UNII: CW657OBU4N)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)  
ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)  
ALCOHOL (UNII: 3K9958V90M)  
PRIMULA VERIS WHOLE (UNII: W6LFQ57E4M)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69231-033-021 in 1 PACKAGE10/24/2022
1NDC:69231-033-0130 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 finalpart35210/24/2022
Labeler - KW ABSC, INC. (079548604)
Registrant - KW ABSC, INC. (079548604)
Establishment
NameAddressID/FEIBusiness Operations
Cit Co., Ltd690081646manufacture(69231-033)

Revised: 10/2022
Document Id: ebd0b625-0f63-8d8b-e053-2995a90a85d7
Set id: aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a2
Version: 1
Effective Time: 20221024
 
KW ABSC, INC.