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| Product NDC Code | 53208-000 | ||||
|---|---|---|---|---|---|
| Drug Name | Isa knox 365 bb sunscreen broad spectrum spf 40, pa |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | LG Household and Healthcare, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Titanium Dioxide 12.16%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply liberally before exposure to the sun. Reapply after excessive perspiration or swimming. Ask a doctor before use on children under 3 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water(Aqua/Eau), Cyclopentasiloxane, Butylene Glycol, Aluminum Starch Octenylsuccinate, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Ascorbyl Glucoside, Neopentyl Glycol Dicaprate, Glycereth-26, Phenyl Trimethicone, Caprylyl Methicone, Dimethicone, Alumina, Dimethicone Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Sodium Chloride, Disteardimonium Hectorite, PEG/PPG-20/15 Dimethicone, Malus Domestica Fruit Cell Culture Extract, Butyrospermum Parkii (Shea) Butter, Citrus Aurantium Dulcis (Orange) Oil, Chamomilla Recutita (Matricaria) Flower Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Olea Europaea (Olive) Fruit Oil, Humulus Lupulus (Hops) Extract, Achillea Millefolium Extract, Melissa Officinalis Leaf Extract, Viscum Album (Mistletoe) Leaf Extract, Dipotassium Glycyrrhizate, SH-Polypeptide-7, Oligopeptide-68, Squalane, Hydrogenated Lecithin, Phytosterols, Ceramide 3, Sodium Hyaluronate, Hydrolyzed Wheat Protein/PVP Crosspolymer, Hydrolyzed Pea Protein, Acrylates/C12-22 Alkyl Methacrylate Copolymer, BetaGlucan, Panthenol, Glycerin, Adenosine, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Tocopherol, Sodium PCA, Allantoin, Lecithin, Methicone, Alcohol, Boron Nitride, Hydroxyethylcellulose, Urea, Xanthan Gum, Potassium Hydroxide, Silica, Triethoxycaprylylsilane, Sodium Oleate, Iron Oxides (C.I. 77491), Iron Oxides (C.I. 77492), Iron Oxides (C.I. 77499), Disodium EDTA, EDTA, Caprylyl Glycol, Phenoxyethanol, Fragrance.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Helps prevent sunburn. Higher SPF gives more sunburn protection.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA TITANIUM DIOXIDE ORANGE OIL WATER CYCLOMETHICONE 5 BUTYLENE GLYCOL ALUMINUM STARCH OCTENYLSUCCINATE ASCORBYL GLUCOSIDE NEOPENTYL GLYCOL DICAPRATE GLYCERETH-26 PHENYL TRIMETHICONE CAPRYLYL TRISILOXANE DIMETHICONE ALUMINUM OXIDE DIPROPYLENE GLYCOL SODIUM CHLORIDE DISTEARDIMONIUM HECTORITE PEG/PPG-20/15 DIMETHICONE SHEA BUTTER CHAMOMILE FENNEL SEED OLIVE OIL HOPS ACHILLEA MILLEFOLIUM MELISSA OFFICINALIS LEAF VISCUM ALBUM FRUITING TOP GLYCYRRHIZINATE DIPOTASSIUM SQUALANE CERAMIDE 3 HYALURONATE SODIUM PANTHENOL GLYCERIN ADENOSINE .ALPHA.-TOCOPHEROL ACETATE PEG/PPG-18/18 DIMETHICONE TOCOPHEROL SODIUM PYRROLIDONE CARBOXYLATE ALLANTOIN ALCOHOL BORON NITRIDE UREA XANTHAN GUM POTASSIUM HYDROXIDE SILICON DIOXIDE TRIETHOXYCAPRYLYLSILANE SODIUM OLEATE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE EDETATE DISODIUM EDETIC ACID CAPRYLYL GLYCOL PHENOXYETHANOL TITANIUM DIOXIDE TITANIUM DIOXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.365 BB SUNSCREEN Broad Spectrum SPF 40, PA+++ ISA KNOX NET WT. 1.7 OZ / 50 g
Product Label IsaKnox
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA Daily BB sunscreen is compatible with makeup base (SPF 40, PA+++). When used, it gives exceptional, long lasting, Broad Spectrum results. It forms a smooth, thin, and supple protective film on the skin that prevents the loss of moisture Distributed by 17777 Center Court Dr. Suite 650, Cerritos, CA 90703, USA Questions? 1-888-498-9004 Made in U.S.A. LG Household and Health Care America
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on irritated or broken skin.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a physician if rash, irritation or sensitivity develops and lasts.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using product do not get into eyes. If eye contact occurs, rinse eyes thoroughly with water.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For External use only. Do not use on irritated or broken skin. Stop use and ask a physician if rash, irritation or sensitivity develops and lasts. When using product do not get into eyes. If eye contact occurs, rinse eyes thoroughly with water. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API