NDC 72935-002 Neora Age Iq Invisi-bloc Sunscreen

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 72935-002

NDC 72935-002-30

Package Description: 1 TUBE in 1 CARTON > 30 mL in 1 TUBE

NDC Product Information

Neora Age Iq Invisi-bloc Sunscreen with NDC 72935-002 is a a human over the counter drug product labeled by Neora, Llc. The generic name of Neora Age Iq Invisi-bloc Sunscreen is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is gel and is administered via topical form.

Labeler Name: Neora, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.


Neora Age Iq Invisi-bloc Sunscreen 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.

  • HOMOSALATE 9.5 g/100mL
  • OCTISALATE 5 g/100mL
  • AVOBENZONE 3 g/100mL
  • OCTOCRYLENE 2.6 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.

  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
  • BETAINE (UNII: 3SCV180C9W)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
  • DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
  • DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • CARNOSINE (UNII: 8HO6PVN24W)
  • LEMON OIL (UNII: I9GRO824LL)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
  • KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
  • WATER (UNII: 059QF0KO0R)
  • HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
  • BASIL OIL (UNII: Z129UMU8LE)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • BROCCOLI (UNII: UOI4FT57BZ)

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.

Product Labeler Information

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

Labeler Name: Neora, Llc
Labeler Code: 72935
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-01-2019 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: 12-31-2020 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.

Neora Age Iq Invisi-bloc Sunscreen Product Label Images

Neora Age Iq Invisi-bloc Sunscreen 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

Other

Drug Facts

Distributed by:Neora, LLC, Dallas, TX 752441.855.463.7486www.neora.com

Otc - Active Ingredient

Active ingredientsAvobenzone 3%Homosalate 9.5%Octisalate 5%Octocrylene 2.6%

Otc - Purpose

PurposeSunscreen

Indications & Usage

  • Useshelps 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

WarningsFor external use only.

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

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.

Dosage & Administration

  • Directionsapply liberally 15 minutes before sun exposure.reapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen 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 sunglasseschildren under 6 months: ask a doctor

Storage And Handling

Other informationProtect this product from excessive heat and direct sun.

Inactive Ingredient

Inactive ingredientsWater, butyloctyl salicylate, dipropylene glycol, caprylyl methicone, methyl trimethicone, betaine, acrylates copolymer, ammonium acryloyldimethyltarate/VP copolymer, hydroxyacetophenone, propanediol, phenoxyethanol, hydrolyzed wheat protein/PVP crosspolymer, dibutyl ethylhexanoyl glutamide, dibutyl lauroyl glutamide, carbomer, citrus aurantium dulcis (orange) peel oil, dipotassium glycyrrhizate, tocopheryl acetate (Vitamin E), aminomethyl propanol, caesalpinia spinosa fruit extract, tropaeolum majus flower/leaf/stem extract, disocium EDTA, carnosine, butylene glycol, citrus limon (lemon) peel oil, citrus aurantium bergamia (bergamot) fruit oil, silica, biosacharride gum-4, kappaphycus alvarezii extract, aloe barbadensis leaf extract, lavandula angustifolia (lavender) oil, ethylhexylglycerin, potassium sorbate, citrus bioflavonoids (vitamin P), hydroxyphenyl propamidobenzoic acid, ocimum basilicum (basil) oil, pelargonium graveolens flower oil, brassica oleracea italica (broccoli) extract, ascorbyl palmitate (Vitamin C).

* Please review the disclaimer below.

Previous Code
72935-001
Next Code
72936-010