NDC 71499-220 Fenty Skin Hydra Vizor Spf 30

Avobenzone, Homosalate, Octisalate

NDC Product Code 71499-220

NDC 71499-220-01

Package Description: 7 mL in 1 TUBE

NDC 71499-220-02

Package Description: 30 mL in 1 TUBE

NDC 71499-220-03

Package Description: 50 mL in 1 BOTTLE

NDC Product Information

Fenty Skin Hydra Vizor Spf 30 with NDC 71499-220 is a a human over the counter drug product labeled by Kendo Holdings Inc. The generic name of Fenty Skin Hydra Vizor Spf 30 is avobenzone, homosalate, octisalate. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Kendo Holdings Inc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Fenty Skin Hydra Vizor Spf 30 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AVOBENZONE 3 g/100mL
  • HOMOSALATE 9 g/100mL
  • OCTISALATE 4.5 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kendo Holdings Inc
Labeler Code: 71499
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-23-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Fenty Skin Hydra Vizor Spf 30 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

AVOBENZONE  3%HOMOSALATE  9%OCTISALATE  4.5%

Purpose

SUNSCREEN

Uses

  • HELPS PREVENT SUNBURNIF 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.

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

  • 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?

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* Please review the disclaimer below.