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| Product NDC Code | 71499-136 | ||||
|---|---|---|---|---|---|
| Drug Name | Fenty skin hydra vizor broad spectrum mineral spf 30 sunscreen moisturizer fragrance-free |
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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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| 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 ZINC OXIDE 15.5%
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, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDES, BUTYLOCTYL SALICYLATE, DIMETHICONE, GLYCERIN, ETHYLHEXYL PALMITATE, PROPANEDIOL, BUTYROSPREMUM PARKII (SHEA) BUTTER, CARTHAMUS TINCTORIUS (SAFFLOWER) .SEED OLEOSOMES, GLYCERYL STEARATE SE, BUTYLENE GLYCOL, POLYHYDROXYSTEARIC ACID, SORBITAN ISOSTEARATE, CETYL ALCOHOL, NIACINAMIDE, PENTAERYTHRITYL TETRAISOSTEARATE, PHENYL TRIMETHICONE, SILICA, HYALURONIC ACID, SODIUM HYALURONATE, CITRULLUS LANATUS (WATERMELON) SEED EXTRACT, ADANSONIA DIGITATA PULP EXTRACT, BAROSMA BETULINA LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE, TOCOPHEROL, GLUCONOLACTONE, INULIN LAURYL CARBAMATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, XANTHAN GUM, HYDROXYACETOPHENONE, POLYSILICONE-11, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, SODIUM CITRATE, CITRIC ACID, BENZYL SALICYLATE, ETHYLHEXYLGLYCERIN, SODIUM BENZOATE, POTASSIUM SORBATE, PHENOXYETHANOL, YELLOW 6, 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 30 SUNSCREEN MOISTURIZER FRAGRANCE-FREE ZINC OXIDE POTASSIUM SORBATE SODIUM BENZOATE FD&C YELLOW NO. 6 ALKYL (C12-15) BENZOATE WATER GLYCERIN BUTYLOCTYL SALICYLATE DIMETHICONE MEDIUM-CHAIN TRIGLYCERIDES SHEA BUTTER NIACINAMIDE HYALURONIC ACID HYALURONATE SODIUM PHENOXYETHANOL ETHYLHEXYL PALMITATE PROPANEDIOL CARTHAMUS TINCTORIUS SEED OLEOSOMES GLYCERYL STEARATE SE BUTYLENE GLYCOL TOCOPHEROL POLYHYDROXYSTEARIC ACID (2300 MW) SORBITAN ISOSTEARATE CETYL ALCOHOL PENTAERYTHRITYL TETRAISOSTEARATE PHENYL TRIMETHICONE SILICON DIOXIDE WATERMELON SEED ADANSONIA DIGITATA FRUIT PULP AGATHOSMA BETULINA LEAF ALOE VERA LEAF GLUCONOLACTONE INULIN LAURYL CARBAMATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) XANTHAN GUM D&C RED NO. 33 ETHYLHEXYLGLYCERIN HYDROXYACETOPHENONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) TRISODIUM ETHYLENEDIAMINE DISUCCINATE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM 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.PRINCIPAL DISPLAY PANEL PACKAGE LABEL PRINCIPAL DISPLAY PANEL
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.
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
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
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