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| Product NDC Code | 76159-001 | ||||
|---|---|---|---|---|---|
| Drug Name | 3lab perfect bb spf 40 broad spectrum 01 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | 3LAB, Inc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Titanium Dioxide 12.16%
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: • Limit time in the sun, especially from 10 a.m. – 2 p.m. • 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 Water (Aqua/Eau),Cyclopentasiloxane, Butylene Glycol, Aluminum Starch Octenylsuccinate, Cetyl PEG/PPG-10/1Dimethicone, PEG-10 Dimethicone, Ascorbyl Glucoside, Caprylyl Methicone, Glycereth-26, Neopentyl Glycol Dicaprate, Phenyl Trimethicone, Dimethicone, Alumina, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol,Sodium Chloride, Disteardimonium Hectorite, Squalane, Achillea Millefolium Extract, Butyrospermum Parkii (Shea Butter), Chamomilla Recutita (Matricaria) Flower Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Humulus Lupulus (Hops) Extract, Malus Domestica Fruit Cell Culture, Melissa Officinalis Leaf Extract, Viscum Album (Mistletoe) Leaf Extract, Olea Europaea (Olive) Fruit Oil, Hydrolyzed Pea Protein, Tocopheryl Acetate, Adenosine, Oligopeptide-68, Rh-Polypeptide-7, Tocopherol, Sodium Hyaluronate, Allantoin, Beta-Glucan, Ceramide 3, Glycerin, Hydrogenated Lecithin, Lecithin, Methicone, Hydroxyethylcellulose, PEG/PPG-20/15 Dimethicone, PEG/PPG-18/18 Dimethicone, Phytosterols, Silica, Sodium Oleate, Sodium PCA, Hydrolyzed Wheat Protein/PVP Crosspolymer, Triethoxycaprylylsilane, Urea, Xanthan Gum, Panthenol, Potassium Hydroxide, Dipotassium Glycyrrhizate, Sodium Phosphate, Caprylyl Glycol, Boron Nitride, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol, Disodium EDTA, EDTA, Phenoxyethanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Fragrance May contain: Iron Oxides (C.I. 77491) Iron Oxides (C.I. 77492) Iron Oxides (C.I. 77499)
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.3LAB PERFECT BB SPF 40 Broad Spectrum 01 TITANIUM DIOXIDE PANTHENOL POTASSIUM HYDROXIDE GLYCYRRHIZINATE DIPOTASSIUM SODIUM PHOSPHATE CAPRYLYL GLYCOL BORON NITRIDE ALCOHOL EDETATE DISODIUM EDETIC ACID PHENOXYETHANOL ORANGE OIL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE WATER CYCLOMETHICONE 5 BUTYLENE GLYCOL ALUMINUM STARCH OCTENYLSUCCINATE ASCORBYL GLUCOSIDE CAPRYLYL TRISILOXANE XANTHAN GUM GLYCERETH-26 NEOPENTYL GLYCOL DICAPRATE PHENYL TRIMETHICONE DIMETHICONE ALUMINUM OXIDE DIPROPYLENE GLYCOL SODIUM CHLORIDE SQUALANE ACHILLEA MILLEFOLIUM SHEA BUTTER CHAMOMILE FENNEL SEED HOPS MELISSA OFFICINALIS LEAF VISCUM ALBUM FRUITING TOP OLIVE OIL .ALPHA.-TOCOPHEROL ACETATE ADENOSINE TOCOPHEROL HYALURONATE SODIUM ALLANTOIN CERAMIDE 3 GLYCERIN PEG/PPG-20/15 DIMETHICONE PEG/PPG-18/18 DIMETHICONE SILICON DIOXIDE SODIUM OLEATE SODIUM PYRROLIDONE CARBOXYLATE TRIETHOXYCAPRYLYLSILANE UREA TITANIUM DIOXIDE TITANIUM DIOXIDE
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.3LAB PERFECT BB SPF 40 BROAD SPECTRUM #01 NET WT. 1.5 OZ. 45 mL e
Product Label Perfect BB 1
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
Other Information Protect this product from excessive heat and direct sun
PERFECT BB SPF 40/PA+++ Infused with 3LAB’s signature bioengineered growth hormone and apple stem cell technology, PERFECT BB SPF 40 is a sheer tinted moisturizer designed to firm and lift the skin, regenerate new skin cells, brighten, moisturize, and protect. Apply to cleansed skin. Directions BIORIUS sprl,2 rue René Descartes,B-7000 Mons, Belgium Distributed by 3LAB,® Inc., Englewood, NJ 07631, U.S.A. www.3LAB.com / Made in U.S.A.
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.
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. 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 product is 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