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Product NDC Code | 71499-103 | ||||
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Drug Name | Fenty skin hydra vizor broad spectrum mineral spf 15 sunscreen hand |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M020 | ||||
Labeler Name | KENDO HOLDINGS INC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS ZINC OXIDE 11%
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. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. 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 SUNCREEN WITH A BROAD SPECTRUM SPF VALUE 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=SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS WATER, GLYCERIN, ISODECYL NEOPENTANOATE, DICAPRYLYL CARBONATE, CESTEARYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDES, MANGIFERA INDICA (MANGO) SEED BUTTER, NIACINAMIDE, HYALURONIC ACID, SODIUM HYALURONATE, ASTROCARYUM MURUMURU SEED BUTTER, HIBISCUS SABDARIFFA SEED OIL, CITRULLUS LANATUS (WATERMELON) SEED OIL, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, MORINGA OLEIFERA SEED OIL, PANTHENOL, TOCOPHEROL, TOCOPHEROL ACETATE, MALPIGHIA PUNICIFOLIA (ACEROLA) FRUIT EXTRACT, LITCHI CHINENSIS FRUIT EXTRACT, GARCINIA MANGOSTANA PEEL EXTRACT, ASCORBYL PALMITATE, CETEARYL GLUCOSIDE, LACTIC ACID, LECITHIN, GLUCOSE, XANTHAN GUM, SODIUM STEAROYL GLUTAMATE, TETRASODIUM GLUTAMATE DIACETATE, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYLGLYCERIN, POLYHYDROXYSTEARIC ACID, PHENOXYETHANOL, CHLORPHENESIN, SODIUM HYDROXIDE, CITRIC ACID, FRAGRANCE, BENZYL SALICYLATE, HEXYL CINNAMA, LIMONENE, LINALOOL, IRON OXIDES, RED 33.
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.FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HAND ZINC OXIDE FERROUS OXIDE WATER GLYCERIN DICAPRYLYL CARBONATE CETOSTEARYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES MANGIFERA INDICA SEED BUTTER NIACINAMIDE HYALURONIC ACID HYALURONATE SODIUM PHENOXYETHANOL ASTROCARYUM MURUMURU SEED BUTTER HIBISCUS SABDARIFFA SEED OIL WATERMELON SEED OIL CRANBERRY SEED OIL MORINGA OLEIFERA SEED OIL PANTHENOL TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE MALPIGHIA GLABRA FRUIT LITCHI FRUIT GARCINIA MANGOSTANA FRUIT RIND ASCORBYL PALMITATE CETEARYL GLUCOSIDE LACTIC ACID, DL- LECITHIN, SOYBEAN ANHYDROUS DEXTROSE XANTHAN GUM SODIUM STEAROYL GLUTAMATE TETRASODIUM GLUTAMATE DIACETATE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE TRIETHOXYCAPRYLYLSILANE D&C RED NO. 33 ETHYLHEXYLGLYCERIN POLYHYDROXYSTEARIC ACID (2300 MW) CHLORPHENESIN SODIUM HYDROXIDE CITRIC ACID MONOHYDRATE LIMONENE, (+)- LINALOOL, (+/-)- BENZYL SALICYLATE ISODECYL NEOPENTANOATE ZINC OXIDE ZINC OXIDE
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.secondary label - hydra vizor hand
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? FENTYSKIN.COM
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. STOP USE AND ASK A DOCTOR IF RASH OCCURS. 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