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Product NDC Code | 10237-004 | ||||
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Drug Name | Hero force shield superbeam sunscreen spf 30 apricot |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | Church & Dwight Co., Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 17.53%
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 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water (aqua), caprylic/capric triglyceride, propanediol, C13-15 alkane, C15-19 alkane, butyloctyl salicylate, bis-diglyceryl polyacyladipate-2, octyldodecanol, cetearyl alcohol, polyacrylate crosspolymer-6, hippophae rhamnoides oil, betaine, mica, musa sapientum (banana) leaf/trunk extract, silica, coco-glucoside, arachidyl alcohol, xanthan gum, polyhydroxystearic acid, polyglyceryl-3 polyricinoleate, isostearic acid, lecithin, polyglyceryl-3 lactate/laurate, polyglycerin-3, bisabolol, tocopherol, behenyl alcohol, caprylhydroxamic acid, sodium dilauramidoglutamide lysine, citric acid, arachidyl glucoside, ectoin, niacinamide, maltodextrin, sodium citrate, sodium phytate, terminalia ferdinandiana fruit extract, lactobacillus ferment, tin oxide, glucose, leuconostoc/radish root ferment filtrate, yellow iron oxide, red iron oxide, titanium dioxide
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. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
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.Hero Force Shield Superbeam Sunscreen SPF 30 Apricot Zinc Oxide Zinc Oxide Zinc Oxide WATER MEDIUM-CHAIN TRIGLYCERIDES PROPANEDIOL C13-15 ALKANE C15-19 ALKANE BUTYLOCTYL SALICYLATE BIS-DIGLYCERYL POLYACYLADIPATE-2 OCTYLDODECANOL CETOSTEARYL ALCOHOL AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) BETAINE MICA BANANA SILICON DIOXIDE COCO GLUCOSIDE ARACHIDYL ALCOHOL XANTHAN GUM ISOSTEARIC ACID POLYGLYCERIN-3 LEVOMENOL TOCOPHEROL DOCOSANOL CAPRYLHYDROXAMIC ACID SODIUM DILAURAMIDOGLUTAMIDE LYSINE CITRIC ACID MONOHYDRATE ARACHIDYL GLUCOSIDE ECTOINE NIACINAMIDE MALTODEXTRIN SODIUM CITRATE, UNSPECIFIED FORM PHYTATE SODIUM KAKADU PLUM STANNIC OXIDE ANHYDROUS DEXTROSE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE FERRIC OXIDE YELLOW FERRIC OXIDE RED 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.PRINCIPAL DISPLAY PANEL - 50 ml Tube Box Hero. FORCE SHIELD Superbeam Sunscreen Broad Spectrum SPF 30 Protects acne-prone skin from UVA/ UVB with Zinc Oxide. Formulated with Pearl + Apricot Pigments. 50 ml / 1.69 fl. oz. PRINCIPAL DISPLAY PANEL - 50 ml Tube Box
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
Distributed by Hero Cosmetics, Inc. New York, NY 10013
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 damaged 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 347-669-0686
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 doctor if irritation becomes severe.
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 this product keep out of eyes. Rinse with water to remove.
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 damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if irritation becomes severe. Keep out of reach of children.
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