CLE CCC OLIVE 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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69231-035_CLE CCC Olive Medium Deep

Titanium Dioxide 8.54%

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, CI 77492, C12-15 Alkyl Benzoate, Cyclomethicone, Cyclopentasiloxane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, CI 77491, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, CI 77499, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Mica, Cyclohexasiloxane, Diisostearyl Malate, Sodium Chloride, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Sorbitan Olivate, Silica, Polyester-1, Silica Dimethyl Silylate, Triethoxycaprylylsilane, Dipropylene Glycol, Hydroxyacetophenone, Vegetable Oil, Chlorphenesin, Propylene Carbonate, Dimethicone, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Adenosine, Cananga Odorata Flower Oil, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, 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, 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 OLIVE MEDIUM DEEP 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69231-035
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 DIOXIDE2.561 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:69231-035-021 in 1 PACKAGE10/25/2022
1NDC:69231-035-0130 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 finalpart35210/25/2022
Labeler - KW ABSC, INC. (079548604)
Registrant - KW ABSC, INC. (079548604)
Establishment
NameAddressID/FEIBusiness Operations
Cit Co., Ltd690081646manufacture(69231-035)

Revised: 10/2022
Document Id: ebe49b87-d9b7-3625-e053-2a95a90ac076
Set id: be4434c0-cbdd-46cb-8015-4c7859e80d4a
Version: 1
Effective Time: 20221025
 
KW ABSC, INC.