NDC 70381-118 Hydration Invisiblur Perfecting Shield Broad Spectrum Spf 30

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 70381-118

NDC CODE: 70381-118

Proprietary Name: Hydration Invisiblur Perfecting Shield Broad Spectrum Spf 30 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avobenzone, Homosalate, Octisalate, Octocrylene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
YELLOW (C48330 - CLEAR TO SLIGHTLY YELLOW)

NDC Code Structure

  • 70381 - Murad, Llc
    • 70381-118 - Hydration Invisiblur Perfecting Shield Broad Spectrum

NDC 70381-118-02

Package Description: 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE (70381-118-01)

NDC Product Information

Hydration Invisiblur Perfecting Shield Broad Spectrum Spf 30 with NDC 70381-118 is a a human over the counter drug product labeled by Murad, Llc. The generic name of Hydration Invisiblur Perfecting Shield Broad Spectrum Spf 30 is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Hydration Invisiblur Perfecting Shield Broad Spectrum 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.


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.

  • ISODODECANE (UNII: A8289P68Y2)
  • DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
  • HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
  • RIBES NIGRUM SEED OIL (UNII: GKE1188837)
  • PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
  • ROSEMARY (UNII: IJ67X351P9)
  • SUNFLOWER SEED (UNII: R9N3379M4Z)
  • CUCUMBER (UNII: YY7C30VXJT)
  • PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
  • OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • C15-23 ALKANE (UNII: J3N6X3YK96)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • ALCOHOL (UNII: 3K9958V90M)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50)
  • SHIITAKE MUSHROOM (UNII: 1A64QN2D2F)
  • MUCOR PLUMBEUS (UNII: D7401PWY6E)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q)

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: Murad, Llc
Labeler Code: 70381
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: 08-30-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hydration Invisiblur Perfecting Shield Broad Spectrum Spf 30 Product Label Images

Hydration Invisiblur Perfecting Shield Broad Spectrum 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

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposeAvobenzone 2.0%SunscreenHomosalate 4.0%SunscreenOctisalate 4.0%SunscreenOctocrylene 2.0%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

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.

Stop Use And Ask A Doctor

  • If skin rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposurereapply at least every 2 hours and after towel drying, swimming, or sweating to avoid lowering protection Sun Protection Measures UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a.m.-2 p.m., and wearing protective clothingchildren under 6 months: Ask a doctor

Inactive Ingredients

Isododecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/Capric Triglyceride, Caprylyl Methicone, Phenyl Trimethicone, Diethylhexyl 2,6-Naphthalate, Hydrogenated Soybean Oil, Ribes Nigrum (Black Currant) Seed Oil, Paeonia Suffruticosa Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Solidago Virgaurea (Goldenrod) Extract, Helianthus Annuus (Sunflower) Seed Extract, Hordeum Vulgare (Barley) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Lentinus Edodes (Shiitake Mushroom) Extract, Mucor Miehei Extract, Propylene Glycol Dicaprate, Tocopheryl Acetate, Retinyl Palmitate, Ascorbic Acid, Octyldodecanol, Octyldodecyl Stearoyl Stearate, Octyldodecyl Oleate, Hydrogenated Soy Polyglycerides, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Butylene Glycol, C15-23 Alkane, PEG-8 Dimethicone, Alcohol, Benzyl Benzoate, Citral, Hexyl Cinnamal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Fragrance (Parfum)

Other Information

  • Protect this product from excessive heat and direct sun

* Please review the disclaimer below.