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Product NDC Code | 76230-727 | ||||
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Drug Name | Everyday facial moisturizer and sunscreen spf 20 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | part352 | ||||
Labeler Name | 714 Essentials LTD | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT: Zinc Oxide 16.32%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Ottilie and Lulu Non-Chemical Sunscreen Smooth Silky Feel Water-Resistant - Dermatologist Tested Allergy Tested - Clinically Tested Not Tested on Animals - Made in the USA Please Visit us at www.ottilieandlulu.com Manufactured exclusively for 714 Essentials LTD. Dba: Ottilie and Lulu'" NY. NY 10024
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 daily before sun exposure Re-apply after swimming.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.OTHER INGREDIENTS: Water, Cyclopentasiloxane, PEG-10 Dimethicone, Dimethicone, Butylene Glycol, Caprylyl Methicone, Isononyl Isononanoate, Dipropylene Glycol, Sodium Chloride, Hydrogenated Polyisobutene, Disteardimonium Hectorite, Dimethiconol, Sodium Hyaluronate, Sodium PCA, Algae Extract, Camellia Sinensis Leaf Extract, Dipotassium Glycyrrhizate, Panthenol, Tocopheryl Acetate, Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, 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.USE: Provides broad spectrum protection against UVA (cause of cancer and aging) and UVB (sunburn) rays. Recommended for all skin types. Its powerful anti-inflammatory and antioxident properties (green tea, algae, and Vitamin E) guard against free radical damage. No ghostly residue. PABA free. Oil free.
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.Everyday Facial Moisturizer And Sunscreen SPF 20 ZINC OXIDE WATER CYCLOMETHICONE 5 DIMETHICONE BUTYLENE GLYCOL ISONONYL ISONONANOATE DIPROPYLENE GLYCOL SODIUM CHLORIDE HYALURONATE SODIUM SODIUM PYRROLIDONE CARBOXYLATE GREEN TEA LEAF GLYCYRRHIZINATE DIPOTASSIUM PANTHENOL SILICON DIOXIDE EDETATE DISODIUM PHENOXYETHANOL CAPRYLYL GLYCOL CHLORPHENESIN ZINC OXIDE ZINC OXIDE
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.Ottilie and Lulu Everyday Facial Moisturizer And Sunscreen SPF 20 Clean, Clear, Healthy Skin For Tweens 2.5 fl oz / 75 ml
Please Visit us at www.ottilieandlulu.com Manufactured exclusively for 714 Essentials LTD. Dba: Ottilie and Lulu'" NY. NY 10024 2.5 fl oz / 75 ml 8 99837 00209 3
Ottilie Lulu1
Ottilie Lulu2
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.Discontinue use if irritation or rash appears.
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.WARNING: For external us only. Do not get into eyes.
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