Label: CLE CCC NEUTRAL FAIR- titanium dioxide, octinoxate, octisalate cream
- NDC Code(s): 69231-033-01, 69231-033-02
- 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 October 24, 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, 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLE CCC NEUTRAL FAIR
titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69231-033 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 0.9 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.757 mg in 30 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69231-033-02 1 in 1 PACKAGE 10/24/2022 1 NDC:69231-033-01 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 10/24/2022 Labeler - KW ABSC, INC. (079548604) Registrant - KW ABSC, INC. (079548604) Establishment Name Address ID/FEI Business Operations Cit Co., Ltd 690081646 manufacture(69231-033)
