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Product NDC Code | 82153-271 | ||||||
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Drug Name | Live tinted hueguard 3-in-1 mineral sunscreen moisturizer primer broad spectrum spf 30 |
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Type | Brand | ||||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
Application Number | M020 | ||||||
Labeler Name | Live Tinted, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 18.23% Purpose 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 liberally to face and neck for everyday moisture and protection. • Can be worn alone or under makeup. • Reapply at least every two hours. • Pair with a water-resistant SPF when swimming or sweating. • • 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 methods such as: • Limit time in the sun, especially from 10 am – 2 pm. • Wear long-sleeve shirts, pants, hats, and sunglasses. • Children under 6 months, ask a doctor. Sun Protection Measures
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients WATER (AQUA), CAPRYLIC / CAPRIC TRIGLYCERIDE, C13-15 ALKANE, PROPANEDIOL, C15-19 ALKANE, BISDIGLYCERYL POLYACYLADIPATE-2, TOCOPHEROL, OCTYLDODECANOL, POLYHYDROXYSTEARIC ACID, INOSITOL, HIPPOPHAE RHAMNOIDES OIL, SILICA, POLYACRYLATE ROSSPOLYMER- 6, ISOSTEARIC ACID, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, XANTHAN GUM, COCO-GLUCOSIDE, POLYGLYCERIN-3, OLYGLYCERYL- 3 LACTATE / LAURATE, BISABOLOL, CAPRYLHYDROXAMIC ACID, SODIUM DILAURAMIDOGLUTAMIDE LYSINE, SODIUM CITRATE, CITRIC ACID, ARACHIDYL GLUCOSIDE, SODIUM PHYTATE, GLYCERIN, PHYSALIS ALKEKENGI CALYX EXTRACT, BIOSACCHARIDE GUM-1, SODIUM LEVULINATE, GLYCERYL CAPRYLATE, CETEARYL ALCOHOL, T-BUTYL ALCOHOL, SODIUM ANISATE, GLUCOSE, BETACAROTENE, BEHENYL ALCOHOL, ARACHIDYL ALCOHOL, IRON OXIDES (CI 77492), IRON OXIDE (CI 77491)
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), helps decrease 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.LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30 ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE PENTYLENE GLYCOL C15-19 ALKANE BIS-DIGLYCERYL POLYACYLADIPATE-2 TOCOPHEROL OCTYLDODECANOL INOSITOL SILICON DIOXIDE AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) ISOSTEARIC ACID XANTHAN GUM COCO GLUCOSIDE POLYGLYCERIN-3 LEVOMENOL CAPRYLHYDROXAMIC ACID SODIUM DILAURAMIDOGLUTAMIDE LYSINE SODIUM CITRATE CITRIC ACID MONOHYDRATE ARACHIDYL GLUCOSIDE PHYTATE SODIUM GLYCERIN PHYSALIS ALKEKENGI CALYX BIOSACCHARIDE GUM-1 SODIUM LEVULINATE GLYCERYL CAPRYLATE CETOSTEARYL ALCOHOL TERT-BUTYL ALCOHOL SODIUM ANISATE ANHYDROUS DEXTROSE BETA CAROTENE DOCOSANOL ARACHIDYL ALCOHOL FERRIC OXIDE RED ZINC OXIDE ZINC CATION
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 Labeling: 150mL Outer Package2 Inner Label2
Package Labeling: 15mL Outer Package Inner Package
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
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. Rinse with water to remove. Keep out of eyes.
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 if rash occurs and ask a doctor.
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. Rinse with water to remove. Keep out of eyes. Stop use if rash occurs and ask a doctor. 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