NDC 59899-051 Age Defense Mineral Moisturizer Spf 30

Titanium Dioxide

NDC Product Code 59899-051

NDC 59899-051-02

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE (59899-051-01)

NDC Product Information

Age Defense Mineral Moisturizer Spf 30 with NDC 59899-051 is a a human over the counter drug product labeled by Shaklee Corporation. The generic name of Age Defense Mineral Moisturizer Spf 30 is titanium dioxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Shaklee Corporation

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.

Age Defense Mineral Moisturizer 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.

  • TITANIUM DIOXIDE 42 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.

  • ALTEROMONAS MACLEODII (UNII: BPX036043D)
  • POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
  • PEA (UNII: W4X7H8GYFM)
  • MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CORIANDER OIL (UNII: 7626GC95E5)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ACACIA DECURRENS WHOLE (UNII: 8KZ75S2VSK)
  • WATER (UNII: 059QF0KO0R)
  • ULVA COMPRESSA (UNII: SXZ209FM33)
  • SQUALANE (UNII: GW89575KF9)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • VITIS VINIFERA SEED (UNII: C34U15ICXA)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TAGETES ERECTA FLOWER (UNII: UH5X33P33E)
  • CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
  • MUSCADINE GRAPE (UNII: 072T3X480E)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
  • CLOVE LEAF OIL (UNII: VCA5491KVF)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

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: Shaklee Corporation
Labeler Code: 59899
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: 06-01-2020 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.

Age Defense Mineral Moisturizer Spf 30 Product Label Images

Age Defense Mineral Moisturizer 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

Otc - Active Ingredient

Titanium Dioxide 4.2%

Otc - Purpose

Sunscreen

Indications & Usage

Helps prevent sunburn

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. Rince with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Ask Doctor

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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

Directions

  • Apply generously 15 minutes before sun exposureChildren under 6 months of age: Ask a doctorSun 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 sunglassesReapply at least every 2 hoursUse a water-resistant sunscreen if swimming or sweating

Other Information

  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredient

Water (Aqua), Glyverin, Dimethicone, Pentylene Glycol, Ethylhexyl Methoxycrylene, Polyester-8, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyclyceryl-3 Polydimethylciloxyethyl Dimethicone, Squalane, Alumina, Phenoxyethanol, Enteromorpha Compressa (Green Algae) Extract, Polysorbate 60, Eugenia Caryophyllus (Clove) Leaf Oil, Hydrogen Dimethicone, Pisum Sativum (Pea) Extract, Carthamus Tinctorius (Safflower) Seed Oil, Ethylhexylglycerin, Acacia Decurrens Extract, Butylene Glycol, Caesalpinia Spinosa (Tara Tree) Gum, Vitis Rotundifolia (muscadine Grape) Fruis Extract, Tagetes Erecta Flower Extract, Cananga Odorata Flower Oil, Citric Acid, Alteromonas Ferment Extract Magnesium Ascorbyl Phosphate (Vitamin C), Panthenol (Vitamin B5), Coriandrum Sativum (Coriander) Fruit Oil, Vitis Vinifera (Grape) Seed Extract, 1,2-Hexanediol, Beta-Glucan, Caprylyl Glycol, Superoxide Dismutase.

* Please review the disclaimer below.