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Product NDC Code | 71499-083 | ||||
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Drug Name | Hydra vizor huez tinted moisturizer broad spectrum spf 30 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
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 INGREDIENT 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 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 TRIGLYCERIDE, C15-19 ALKANE, BUTYLOCTYL SALICYLATE, PHENYL TRIMETHICONE, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, DIMETHICONE, SORBITAN ISOSTEARATE, ETHYLHEXYL PALMITATE, BUTYLENE GLYCOL, QUATERNIUM-90 BENTONITE, POLYHYDROXYSTEARIC ACID, NIACINAMIDE, 1,2-HEXANEDIOL, ADANSONIA DIGITATA PULP EXTRACT, ALOE BARBADENSIS LEAF JUICE, BAROSMA BETULINA LEAF EXTRACT, CAPRYLYL GLYCOL, CAPRYLYL/CAPRYL GLUCOSIDE, CETYL ALCOHOL, CITRIC ACID, CITRULLUS LANATUS (WATERMELON) SEED EXTRACT, DISTEARDIMONIUM HECTORITE, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL STEARATE SE, HYALURONIC ACID, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOPROPYL TITANIUM TRIISOSTEARATE, PHENOXYETHANOL, POLYISOBUTENE, POLYSILICONE-11, POTASSIUM SORBATE, SILICA, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SODIUM BENZOATE, SODIUM HYALURONATE, SORBITAN OLEATE, TOCOPHEROL, TOCOPHERYL ACETATE, TRIETHYL CITRATE, XANTHAN GUM. MAY CONTAIN (+/-): IRON OXIDES,TITANIUM DIOXIDE.
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.HYDRA VIZOR HUEZ TINTED MOISTURIZER BROAD SPECTRUM SPF 30 ZINC OXIDE BUTYLENE GLYCOL ISOPROPYL TITANIUM TRIISOSTEARATE SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) SODIUM BENZOATE CAPRYLYL/CAPRYL OLIGOGLUCOSIDE SORBITAN ISOSTEARATE ANHYDROUS CITRIC ACID CETYL ALCOHOL WATERMELON SEED DISTEARDIMONIUM HECTORITE GLYCERYL STEARATE SE HYALURONATE SODIUM .ALPHA.-TOCOPHEROL GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE HYALURONIC ACID DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) POTASSIUM SORBATE XANTHAN GUM PHENOXYETHANOL SILICON DIOXIDE C15-19 ALKANE BUTYLOCTYL SALICYLATE PHENYL TRIMETHICONE TRIETHYL CITRATE ETHYLHEXYL PALMITATE QUATERNIUM-90 BENTONITE NIACINAMIDE ADANSONIA DIGITATA FRUIT PULP BROWN IRON OXIDE POLYHYDROXYSTEARIC ACID (2300 MW) POLYISOBUTYLENE (1300 MW) TITANIUM DIOXIDE GLYCERIN HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SORBITAN MONOOLEATE AGATHOSMA BETULINA LEAF MEDIUM-CHAIN TRIGLYCERIDES ZINC OXIDE ZINC OXIDE 1,2-HEXANEDIOL CAPRYLYL GLYCOL ALKYL (C12-15) BENZOATE DIMETHICONE 20 ALOE VERA LEAF WATER ETHYLHEXYLGLYCERIN .ALPHA.-TOCOPHEROL ACETATE
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
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. 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