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| Product NDC Code | 61197-217 | ||||
|---|---|---|---|---|---|
| Drug Name | Glow baby super lit spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | M020 | ||||
| Labeler Name | Pacifica Beauty, 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 ingredients Purpose Zinc Oxide 20.8% Sunscreen
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 and reapply at least every 80 minutes. Sun protection measures. Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeve shirts, pants, hats & sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Aqua (Eau), Allantoin, Ascorbic Acid, Bisabolol, Bismuth Oxychloride, Butyloctyl Salicylate, Caffeine, Caprylhydroxamic acid, Caprylic/ Capric Triglyceride, Citric Acid, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Iron Oxides (CI 77491, CI 77492, CI 77499), Jojoba Esters, Malus Domestica Fruit Cell Culture Extract, Mica, Parfum*, Polyglyceryl-6 Distearate, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil (and) Sodium Benzoate, Sodium Stearoyl Glutamate, Sorbitan Sesquioleate, Terminalia Ferdinandiana Fruit Extract, Titanium Dioxide, Tocopherol (Vitamin E), Tocopheryl Acetate, Xanthan Gum.
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.If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.
Spl product data elements
Usually a list of ingredients in a drug product.Glow Baby Super Lit SPF 30 Zinc Oxide MALUS DOMESTICA WHOLE POLYGLYCERYL-6 POLYRICINOLEATE SILICON DIOXIDE POLYHYDROXYSTEARIC ACID (2300 MW) MICA GLYCERYL STEARATE SE CAFFEINE CAPRYLHYDROXAMIC ACID SODIUM STEAROYL GLUTAMATE KAKADU PLUM XANTHAN GUM FERRIC OXIDE RED FERROSOFERRIC OXIDE ZINC OXIDE ZINC OXIDE TOCOPHEROL ALPHA-TOCOPHEROL ACETATE JOJOBA OIL SODIUM BENZOATE SORBITAN SESQUIOLEATE TITANIUM DIOXIDE .ALPHA.-BISABOLOL, (+)- FERRIC OXIDE YELLOW ASCORBIC ACID HYDROLYZED JOJOBA ESTERS (ACID FORM) ALLANTOIN GLYCERYL CAPRYLATE BISMUTH OXYCHLORIDE BUTYLOCTYL SALICYLATE MEDIUM-CHAIN TRIGLYCERIDES WATER CITRIC ACID MONOHYDRATE GLYCERIN
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.Glow Baby Super Lit SPF 30 Lotion Label Glow Baby Super Lit SPF 30 Lotion Label
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? Call toll free 1-888-322-2466 Pacifica Beauty LLC Portland, Oregon
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product from excessive heat & 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. Stop use & ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Can stain clothing. Keep away from clothes. Children under 6 months: ask a doctor.
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