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Product NDC Code | 69219-107 | ||||||||||
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Drug Name | Eclipse spf 50 perfectint beige |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | LOTION | ||||||||||
Application Number | M020 | ||||||||||
Labeler Name | SCIENCE OF SKINCARE LLC | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients TITANIUM DIOXIDE – 5.20% Zinc Oxide – 1.10%
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 40 MINUTES OF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS • 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: o limit time in the sun, especially from 10 a.m.-2 p.m. o wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients 1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alumina, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Disodium EDTA, Dimethicone, Glyceryl Stearate, Methicone, Octyldodecyl Neopentanoate, PEG-100 Stearate, Polyhydroxystearic Acid, Sorbitan Laurate, Styrene/Acrylates Copolymer, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water/Aqua/Eau, Xanthan Gum +/- Iron Oxides.
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 hydrate and 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.ECLIPSE SPF 50 PERFECTINT BEIGE TITANIUM DIOXIDE, ZINC OXIDE 1,2-HEXANEDIOL ALUMINUM BUTYLENE GLYCOL ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE EDETATE DISODIUM GLYCERYL MONOSTEARATE OCTYLDODECYL NEOPENTANOATE PEG-100 STEARATE POLYHYDROXYSTEARIC ACID (2300 MW) SORBITAN MONOLAURATE STYRENE TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE TRIETHOXYCAPRYLYLSILANE VINYLPYRROLIDONE/EICOSENE COPOLYMER WATER XANTHAN GUM TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW
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.Package Label - Principal Display Panel 69219-107-11 69219-107-01
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 product is swallowed,get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.
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 Customer Care at (888) 804-4447
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
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