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| Product NDC Code | 82069-101 | ||||
|---|---|---|---|---|---|
| Drug Name | Tinted mineral sunscreen 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 | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Buttah Enterprises, LLC. | ||||
| 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 2.5% ZINC OXIDE 6%
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 AND EVENLY 15 MINUTES BEFORE SUN EXPOSURE REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. 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 AM TO 2 PM. WEAR LONG-SLEEVED 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), Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, Dimethicone, Glycerin, C12-15 Alkyl Benzoate, PEG-100 Stearate, Glyceryl STearate, Cetyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Cyclohexasiloxane, Sucrose Cocoate, Citric Acid, Sodium Citrate, Sodium PCA, Glyceryl Isostearate, Alumina, Caprylyl Methicone, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Iron Oxides, Allantoin, Xanthan Gum, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glyceryl Undecylenate, Panthenol, Phytic Acid, Sodium Hyaluronate.
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.TINTED MINERAL SUNSCREEN SPF-30 TITANIUM DIOXIDE, ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES CYCLOMETHICONE 5 PROPANEDIOL DIMETHICONE GLYCERIN ALKYL (C12-15) BENZOATE PEG-100 STEARATE GLYCERYL MONOSTEARATE CETYL ALCOHOL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) GLYCERYL CAPRYLATE CYCLOMETHICONE 6 SUCROSE COCOATE ANHYDROUS CITRIC ACID SODIUM CITRATE SODIUM PYRROLIDONE CARBOXYLATE GLYCERYL ISOSTEARATE ALUMINUM OXIDE CAPRYLYL TRISILOXANE POLYHYDROXYSTEARIC ACID (2300 MW) DIMETHICONE 100 LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE CHLORPHENESIN FERRIC OXIDE RED FERRIC OXIDE YELLOW ALLANTOIN XANTHAN GUM GREEN TEA LEAF MATRICARIA RECUTITA FLOWERING TOP CUCUMBER GLYCERYL 1-UNDECYLENATE PANTHENOL FYTIC ACID HYALURONATE SODIUM ZINC OXIDE ZINC CATION 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.0-LBL_Buttah_Tinted Mineral Sunscreen SPF30_2oz
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 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.QUESTIONS OR COMMENTS call toll free: 1-833-428-8824
Storage and handling
Information about safe storage and handling of the drug product.CALL TOLL FREE: 1-800-428-8824
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 DAMAGE 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.
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