Active Ingredient
ZINC OXIDE 15.5%
Hydra Vizor Huez Tinted Moisturizer Lotion
FDA Label NDC 71499-083
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kendo Holdings Inc. for the product Hydra Vizor Huez Tinted Moisturizer (NDC 71499-083). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
SUNSCREEN
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.
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.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
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.
Other Information
PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
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.
Questions?
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Package Label.Principal Display Panel
Principal Display Panel (Hydra Vizor Huez Spf Drug Label)
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