NDC 68479-909 Invisible Physical Defense Spf 30

Zinc Oxide

NDC Product Code 68479-909

NDC 68479-909-00

Package Description: 177 mL in 1 TUBE

NDC 68479-909-01

Package Description: 1 TUBE in 1 CARTON > 7 mL in 1 TUBE

NDC 68479-909-02

Package Description: 50 mL in 1 TUBE

NDC 68479-909-04

Package Description: 177 mL in 1 TUBE

NDC Product Information

Invisible Physical Defense Spf 30 with NDC 68479-909 is a a human over the counter drug product labeled by Dermalogica, Inc.. The generic name of Invisible Physical Defense Spf 30 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Dermalogica, 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.

Invisible Physical Defense 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.

  • ZINC OXIDE 200 mg/mL

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)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • OPHIOCORDYCEPS SINENSIS (UNII: 8Q1GYP08KU)
  • TRAMETES VERSICOLOR FRUITING BODY (UNII: 4C900477MT)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • LAVANDIN OIL (UNII: 9RES347CKG)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: Dermalogica, Inc.
Labeler Code: 68479
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: 03-05-2020 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.

Invisible Physical Defense Spf 30 Product Label Images

Invisible Physical Defense 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

Active Ingredient

Zinc Oxide (20%)

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.If used as directed with other sun protection measures (see Directions), helps decrease 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.

When Using This Product

  • Keep out of eyes. Rinse with water to remove.

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.

Directions

  • Apply liberally 30 minutes before sun exposure.Reapply at least every two hours.Use a water resistant sunscreen if swimming or sweating.Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses.Children under 6 months: ask a doctor.

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dimethicone, Butyloctyl Salicylate, Butylene Glycol, Glycerin, Silica, Polyhydroxystearic Acid, PEG-10 Dimethicone, Argania Spinosa Kernel Oil, Cordyceps Sinensis Extract, Trametes Versicolor Extract, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Oil, Lavandula Spica (Lavender) Flower Oil, Tocopheryl Acetate, Sodium Chloride, Stearalkonium Hectorite, Pentylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Propanediol, Dimethicone Crosspolymer, Sodium Citrate, Propylene Carbonate, Xanthan Gum, Caprylyl Glycol, Bisabolol, Lavandula Hybrida Oil, Ethylhexylglycerin, Sodium Hydroxide, Potassium Sorbate, Sodium Benzoate.

* Please review the disclaimer below.