Label: CLE CCC GOLDEN MEDIUM DEEP- titanium dioxide, octinoxate, octisalate cream
- NDC Code(s): 69231-027-01, 69231-027-02
- Packager: KW ABSC, INC.
- Category: HUMAN OTC DRUG LABEL
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 December 3, 2018
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- PURPOSE
- ACTIVE INGREDIENT
- 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, Cyclomethicone, Iron Oxides (CI 77492), C12-15 Alkyl Benzoate, Butylene Glycol, Cyclopentasiloxane, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Mica (CI 77019), Niacinamide, Dicaprylyl Carbonate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cyclohexasiloxane, Ceresin, Iron Oxides (CI 77491), Diisostearyl Malate, Sodium Chloride, Polyester-1, Silica, Silica Dimethyl Silylate, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Sorbitan Olivate, Iron Oxides (CI 77499), Vegetable Oil, Chlorphenesin, Dipropylene Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, 1,2-Hexanediol, Propylene Carbonate, Hydroxyacetophenone, Dimethicone, Cananga Odorata Flower Oil, Adenosine, 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, Tocopherol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLE CCC GOLDEN MEDIUM DEEP
titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69231-027 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 2.51454 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) AMILOXATE (UNII: 376KTP06K8) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) MICA (UNII: V8A1AW0880) NIACINAMIDE (UNII: 25X51I8RD4) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) BEMOTRIZINOL (UNII: PWZ1720CBH) CERESIN (UNII: Q1LS2UJO3A) FERRIC OXIDE RED (UNII: 1K09F3G675) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) SORBITAN OLIVATE (UNII: MDL271E3GR) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CORN OIL (UNII: 8470G57WFM) CHLORPHENESIN (UNII: I670DAL4SZ) DIPROPYLENE GLYCOL (UNII: E107L85C40) BERGAMOT OIL (UNII: 39W1PKE3JI) ORANGE OIL (UNII: AKN3KSD11B) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) DIMETHICONE (UNII: 92RU3N3Y1O) CANANGA OIL (UNII: 8YOY78GNNX) ADENOSINE (UNII: K72T3FS567) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69231-027-02 1 in 1 PACKAGE 12/03/2018 1 NDC:69231-027-01 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 12/03/2018 Labeler - KW ABSC, INC. (079548604) Registrant - KW ABSC, INC. (079548604) Establishment Name Address ID/FEI Business Operations Cit Co., Ltd 690081646 manufacture(69231-027)
