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| Product NDC Code | 59062-1001 | ||||||||
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| Drug Name | Spf 50 mineral sunscreen babyganics |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | KAS Direct LLC dba BabyGanics | ||||||||
| 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 Titanium dioxide 3%, Zinc oxide 12%
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: 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 water, ethylhexyl palmitate, butyloctyl salicylate, caprylic/capric triglyceride, trimethylpentanediol/adipic acid/glycerin crosspolymer, cetearyl olivate, glycerin, sorbitan olivate, tocopheryl acetate, phenoxyethanol, cetearyl alcohol, cetearyl glucoside, propanediol, alumina, xanthan gum, jojoba esters, 1,2-hexanediol, bisabolol, helianthus annuus (sunflower) seed oil Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic • *Learn about these and all our ingredients and the choices we make at babyganics.com/products , solanum lycopersicum (tomato) seed oil, lecithin, polyhydroxystearic acid, caprylhydroxamic acid, citric acid, isopropyl myristate, isostearic acid, polyglyceryl-3 polyricinoleate, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil , rubus idaeus (red raspberry) seed oil
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.SPF 50 Mineral Sunscreen Babyganics titanium dioxide and zinc oxide Titanium Dioxide Titanium Dioxide ZINC OXIDE ZINC OXIDE WATER Ethylhexyl Palmitate Butyloctyl Salicylate MEDIUM-CHAIN TRIGLYCERIDES TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) Cetearyl Olivate GLYCERIN Sorbitan Olivate .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL CETOSTEARYL ALCOHOL Cetearyl Glucoside Propanediol ALUMINUM OXIDE XANTHAN GUM JOJOBA OIL, RANDOMIZED 1,2-Hexanediol .ALPHA.-BISABOLOL, (+/-)- SUNFLOWER OIL TOMATO SEED OIL POLYHYDROXYSTEARIC ACID (2300 MW) Caprylhydroxamic Acid Isopropyl Myristate Isostearic Acid POLYGLYCERYL-3 PENTARICINOLEATE CRANBERRY SEED OIL Nigella Sativa Seed Oil RASPBERRY SEED OIL LECITHIN, SOYBEAN CITRIC ACID MONOHYDRATE SPF 50 Mineral Sunscreen bkids titanium dioxide and zinc oxide Titanium Dioxide Titanium Dioxide ZINC OXIDE ZINC OXIDE WATER Ethylhexyl Palmitate Butyloctyl Salicylate MEDIUM-CHAIN TRIGLYCERIDES TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) Cetearyl Olivate GLYCERIN Sorbitan Olivate .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL CETOSTEARYL ALCOHOL Cetearyl Glucoside Propanediol ALUMINUM OXIDE XANTHAN GUM JOJOBA OIL, RANDOMIZED 1,2-Hexanediol .ALPHA.-BISABOLOL, (+/-)- SUNFLOWER OIL TOMATO SEED OIL POLYHYDROXYSTEARIC ACID (2300 MW) Caprylhydroxamic Acid Isopropyl Myristate Isostearic Acid POLYGLYCERYL-3 PENTARICINOLEATE CRANBERRY SEED OIL Nigella Sativa Seed Oil RASPBERRY SEED OIL LECITHIN, SOYBEAN CITRIC ACID MONOHYDRATE
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 - 59 mL Tube Label - 59062-1001 non allergenic tear free babyganics ® SPF 50 mineral sunscreen pediatrician tested broad spectrum SPF 50 water resistant (80 minutes) made without oxybenzone, octinoxate, parabens, fragrance, nano-particles Discover which of our ingredients are certified organic on the back panel. 2 FL OZ (59 mL) Principal Display Panel - 59 mL Tube Label - 59062-1001
PRINCIPAL DISPLAY PANEL - 59 mL Tube Label - 59062-1101 tear free kids by babyganics ® easy rub-in SPF 50 mineral sunscreen dermatologist tested broad spectrum SPF 50 water & sweat resistant (80 minutes) made without oxybenzone, octinoxate, parabens, fragrance Discover which of our ingredients are certified organic on the back panel. 2 FL OZ (59 mL) Principal Display Panel - 59 mL Tube Label - 59062-1101
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
dist. by KAS Direct, LLC san francisco, ca 94111
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. If 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 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 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 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 rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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