Label: CLE CCC WARM DEEP- titanium dioxide, octinoxate, octisalate, avobenzone cream
- NDC Code(s): 69231-032-01, 69231-032-02
- Packager: KW ABSC, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 8, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
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 - WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Cyclopentasiloxane, Butylene Glycol, Diphenylsiloxy Phenyl Trimethicone, C12-15 Alkyl Benzoate, CI 77492, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, CI 77491, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, CI 77499, Polymethyl Methacrylate, Sodium Chloride, Euphorbia Cerifera (Candelilla) Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Trihydroxystearin, Dipropylene Glycol, Hydroxyacetophenone, Vegetable Oil, Chlorphenesin, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Propylene Carbonate, Dimethiconol, Adenosine, Cananga Odorata Flower Oil, Dimethicone, 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, Mica, Tocopherol, Polyester-1, Silica Dimethyl Silylate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLE CCC WARM DEEP
titanium dioxide, octinoxate, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69231-032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.1 mg in 30 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.6 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.51 mg in 30 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.156 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 6 (UNII: XHK3U310BA) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AMILOXATE (UNII: 376KTP06K8) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) NIACINAMIDE (UNII: 25X51I8RD4) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) MICA (UNII: V8A1AW0880) BEMOTRIZINOL (UNII: PWZ1720CBH) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) FERRIC OXIDE RED (UNII: 1K09F3G675) CANDELILLA WAX (UNII: WL0328HX19) SODIUM CHLORIDE (UNII: 451W47IQ8X) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYESTER-10 (UNII: 212N9O2MMZ) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) SORBITAN OLIVATE (UNII: MDL271E3GR) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CORN OIL (UNII: 8470G57WFM) CHLORPHENESIN (UNII: I670DAL4SZ) DIPROPYLENE GLYCOL (UNII: E107L85C40) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BERGAMOT OIL (UNII: 39W1PKE3JI) ORANGE OIL (UNII: AKN3KSD11B) PROPYLENE CARBONATE (UNII: 8D08K3S51E) DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) YLANG-YLANG OIL (UNII: 8YOY78GNNX) DIMETHICONE (UNII: 92RU3N3Y1O) LOWBUSH BLUEBERRY (UNII: G90PX41VP0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) ADENOSINE (UNII: K72T3FS567) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ROSEMARY (UNII: IJ67X351P9) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) THYME (UNII: CW657OBU4N) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69231-032-02 1 in 1 PACKAGE 11/08/2022 1 NDC:69231-032-01 30 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/08/2022 Labeler - KW ABSC, INC. (079548604) Registrant - KW ABSC, INC. (079548604) Establishment Name Address ID/FEI Business Operations Cit Co., Ltd 690081646 manufacture(69231-032)
