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| Product NDC Code | 70793-033 | ||||
|---|---|---|---|---|---|
| Drug Name | Zoey naturals broad spectrum spf 50 fragrance free sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | part352 | ||||
| Labeler Name | Absolutely Natural | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 19%
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 and evenly 15 minutes prior to sun exposure. • Reapply after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours. • Children under 6 months of age: Ask a doctor. 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed wax, olea europaea (olive) oil unsaponifiables, rhus verniciflua peel wax, shorea robusta resin, lauryl laurate, polyhydroxystearic acid, theobroma cacao (cocoa) seed butter, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax, calcium silicate, argania spinosa kernel oil, tocopheryl acetate, bisabolol, butyrospermum parkii (shea) butter, glyceryl caprylate, glyceryl undecylenate, citrus aurantium dulcis peel wax, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol.
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 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.Zoey naturals Broad Spectrum SPF 50 Fragrance Free Sunscreen Zinc Oxide ZINC OXIDE ZINC OXIDE COCONUT OIL CANDELILLA WAX HELIANTHUS ANNUUS SEED WAX OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX SHOREA ROBUSTA RESIN LAURYL LAURATE POLYHYDROXYSTEARIC ACID (2300 MW) COCOA BUTTER MEDIUM-CHAIN TRIGLYCERIDES CARNAUBA WAX CALCIUM SILICATE ARGAN OIL .ALPHA.-TOCOPHEROL ACETATE LEVOMENOL SHEA BUTTER GLYCERYL MONOCAPRYLATE GLYCERYL 1-UNDECYLENATE ORANGE PEEL WAX RICE BRAN ROSEMARY HELIANTHUS ANNUUS FLOWERING TOP TOCOPHEROL
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.Packaging Sunscreen-033
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
WATER RESISTANT (80 MINUTES) MINERAL SUNSCREEN, VEGAN MINERAL FACE & BODY STICK helps prevent sunburn and is infused with nutrients to keep your little one's skin nourished while in the sun. √ Reef Safe √ Sensitive Skin √ Hypoallergenic √ No Harsh Chemicals ZOEY naturals ® is formulated for babies and loved by mamas all around the world. Our effective and gentle formulas are free of harsh chemicals and safe on the environment. Distributed by: Zoey Naturals 640 Atlantis Road, Melbourne, FL 32904 www. Zoey-Naturals.com made for babies. loved by mamas. ® Cruelty free MADE IN USA
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 swallowed, get medical help, or contact Poison Control right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call us! 800-848-8498
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. 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 doctor if rash occurs. Keep out of reach of children . If swallowed, get medical help, or contact Poison Control 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