Label: FENTY SKIN HYDRA VIZOR SPF 30- avobenzone, homosalate, octisalate lotion

  • NDC Code(s): 71499-220-01, 71499-220-02, 71499-220-03
  • Packager: KENDO HOLDINGS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 13, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    AVOBENZONE  3%

    HOMOSALATE  9%

    OCTISALATE  4.5%

  • 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

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • 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, GLYCERIN, CARTHAMUS TINCTORIUS SEED OLEOSOMES, PENTYLENE GLYCOL, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, NIACINAMIDE, ZEA MAYS (CORN) STARCH, HYALURONIC ACID, SODIUM HYALURONATE, CITRULLUS LANATUS (WATERMELON) SEED EXTRACT, ADANSONIA DIGITATA PULP EXTRACT, BAROSMA BETULINA LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, GLUCONOLACTONE, SORBITAN OLEATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, DIMETHICONE, ISOHEXADECANE, ETHYLHEXYL METHOXYCRYLENE, POLYSORBATE 80, XANTHAN GUM, SODIUM HYDROXIDE, CITRIC ACID, POTASSIUM HYDROXIDE, TOCOPHEROL, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, ETHYLHEXYLGLYCERIN, SODIUM BENZOATE, POTASSIUM SORBATE, PHENOXYETHANOL, FRAGRANCE, BENZYL SALICYLATE, CITRAL, HEXYL CINNAMAL, LIMONENE, LINALOOL, RED 33.

  • QUESTIONS?

    FENTYSKIN.COM

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Fenty Skin_Hydra Vizor_30mL

    01b LBL_Fenty Skin_Hydra Vizor_30mL_drug facts box

  • INGREDIENTS AND APPEARANCE
    FENTY SKIN HYDRA VIZOR   SPF 30
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71499-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    AGATHOSMA BETULINA LEAF (UNII: 369DDH39Z0)  
    WATERMELON SEED (UNII: N364973Y9Q)  
    ADANSONIA DIGITATA FRUIT PULP (UNII: P65OHK3GHP)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    CITRAL (UNII: T7EU0O9VPP)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71499-220-017 mL in 1 TUBE; Type 0: Not a Combination Product08/23/2020
    2NDC:71499-220-0230 mL in 1 TUBE; Type 0: Not a Combination Product08/23/2020
    3NDC:71499-220-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product08/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/23/2020
    Labeler - KENDO HOLDINGS INC (078489982)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545manufacture(71499-220)