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Product NDC Code | 26052-027 | ||||
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Drug Name | Renewal firming day broad spectrum spf 30 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | BURT'S BEES, INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Titanium Dioxide 2.53% Zinc Oxide 11.9%
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 gemerpis;u 15 minutes before sun exposure Use in the morning after cleansing Gently smooth over face & neck Children under 6 months: 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 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-sleeve shirts, pants, hats and sunglasses reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.water, glycerin, caprylic/capric triglyceride, decyl oleate, isoamyl cocoate, isoamyl laurate, fragrance, cetyl alcohol, helianthus annuus (sunflower) seed oil, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-4 caprate, glyceryl stearate citrate, stearic acid, hibiscus sabdariffa flower extract, pyrus malus (apple) fruit extract, adansonia digitata fruit extract, scutellaria alpina flower/leaf/stem extract, trifolium pratense (clover) leaf extract, phragmites communis extract, poria cocos extract, beeswax, ribose, sorbitan stearate, stearyl alcohol, isostearic acid, polyhydroxystearic acid, sodium carboxymethyl C10-16 alkyl glucoside, alumina, behenyl alcohol, lesichin, polyglyceryl-3 polyricinoleate, lauryl glucoside, magnesium aluminum silicate, xanthan gum, citric acid, bisabolol, tocopherol, dipotassium glycyrrhizate, arachidyl alcohol, glycine soja (soybean) oil, sodium phytate, sodium lactate, sorbic acid, sodium PCA, sodium citrate, alcohol denat., sodium benzoate, potassium sorbate, phenoxyethanol, eugenol, limonene, linalool.
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.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.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Renewal Firming Day Broad Spectrum SPF 30 Titanium Dioxide, Zinc Oxide POLYHYDROXYSTEARIC ACID (2300 MW) YELLOW WAX RIBOSE, D- ALUMINUM OXIDE DOCOSANOL LECITHIN, SOYBEAN LAURYL GLUCOSIDE ANHYDROUS CITRIC ACID .ALPHA.-BISABOLOL, (+/-)- LENS CULINARIS FRUIT SODIUM LACTATE SODIUM BENZOATE POTASSIUM SORBATE TITANIUM DIOXIDE TITANIUM DIOXIDE GLYCERIN ISOAMYL LAURATE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE CETYL ALCOHOL GLYCERYL STEARATE CITRATE STEARIC ACID PHENOXYETHANOL STEARYL ALCOHOL ISOSTEARIC ACID MEDIUM-CHAIN TRIGLYCERIDES DECYL OLEATE ISOAMYL COCOATE ZINC OXIDE ZINC OXIDE WATER SUNFLOWER OIL SORBITAN MONOSTEARATE XANTHAN GUM TOCOPHEROL PHYTATE SODIUM ARACHIDYL ALCOHOL SOYBEAN OIL HIBISCUS SABDARIFFA FLOWER SORBIC ACID ALCOHOL APPLE PHRAGMITES AUSTRALIS WHOLE FU LING CITRULLUS LANATUS VAR. LANATUS WHOLE MAGNESIUM ALUMINUM SILICATE GLYCYRRHIZINATE DIPOTASSIUM ADANSONIA DIGITATA FRUIT SCUTELLARIA ALPINA FLOWERING TOP SODIUM PYRROLIDONE CARBOXYLATE TRIFOLIUM PRATENSE LEAF SODIUM CITRATE
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.BURT'S BEES RENEWAL FIRMING day lotion with Hibiscus and Apple Rejuvinating Complex BROAD SPECTRUM SPF 30 Clinically shown to: Reduce look of deep wrinkles Help improve firmness Net Wt. 2.0 oz / 56.7 g Renewal SPF 30
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.(800) 849-7112 or www.burtsbees.com
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.
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.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.
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