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| Product NDC Code | 61354-115 | ||||
|---|---|---|---|---|---|
| Drug Name | Cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Oxygen Development LLC | ||||
| 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 ingredient Zinc Oxide 22.4%
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. Use water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun protection measures: Spending time in the sun increases 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 am-2 pm. -wear long-sleeved shirts, pants, hats and sunglasses. -children under 6 months of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water(Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice*, Pyrus Malus (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus (Raspberry) Seed Oil, Cocos Nucifera (Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizinate, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Caprylyl/Capryl Glucoside, Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Tapioca Starch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contain +/- Iron Oxides (CI 77491, CI 77492) *Certified Organic.
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 Help prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agung 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.Cream Zinc Oxide POLYGLYCERYL-3 PENTARICINOLEATE WATER APPLE COCO GLUCOSIDE POLYHYDROXYSTEARIC ACID (2300 MW) LECITHIN, SUNFLOWER MEDIUM-CHAIN TRIGLYCERIDES ZINC OXIDE ZINC OXIDE COCONUT ALKANES RASPBERRY SEED OIL PHENOXYETHANOL LACTOBACILLUS REUTERI F275 STRAIN GLYCERIN CETOSTEARYL ALCOHOL ISOSTEARIC ACID
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.61354-115-01-aw 61354-115-01_aw
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 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 If product is swallowed, 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 doctor Stop use and ask a doctor if rash occurs.
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 When using this product keep out of eyes. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product from excessive heat and direct sun.
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.
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