NDC 71270-252 Trader Joes Enrich Moisturizing Face Broad Spectrum Spf 15

Octinoxate, Zinc Oxide

NDC Product Code 71270-252

NDC 71270-252-11

Package Description: 29 mL in 1 TUBE

NDC 71270-252-14

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Trader Joes Enrich Moisturizing Face Broad Spectrum Spf 15 with NDC 71270-252 is a a human over the counter drug product labeled by Trader Joe's Company. The generic name of Trader Joes Enrich Moisturizing Face Broad Spectrum Spf 15 is octinoxate, zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Trader Joe's Company

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.

Trader Joes Enrich Moisturizing Face Broad Spectrum Spf 15 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.

  • OCTINOXATE 6 g/100mL
  • ZINC OXIDE 3 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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • LAURETH-7 (UNII: Z95S6G8201)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

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: Trader Joe's Company
Labeler Code: 71270
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: 07-09-2019 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: 12-31-2021 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.

Trader Joes Enrich Moisturizing Face Broad Spectrum Spf 15 Product Label Images

Trader Joes Enrich Moisturizing Face Broad Spectrum Spf 15 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 Ingredient

Octinoxate 6%Zinc Oxide 3%

Purpose

Sunscreen

Uses

  • Daily moisturizer that helps prevent sunburn.If 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.When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water.Stop using if rash or irritation occurs and consult a Doctor.Do not use on damaged or broken skin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Apply liberally on face and neck 15 minutes before sun exposure.Use a water resistant sunscreen if swimming or sweating.Reapply at least every 2 hours.Consult a doctor before use on children under six months of age.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 sunscreen with a Broad Spectrum SPF 15 value or higher along with 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.

Inactive Ingredients

ALLANTOIN, ASCORBIC ACID, CAPRYLYL GLYCOL, CETYL ALCOHOL, CHLORPHENESIN, CYCLOMETHICONE, CYCLOPENTASILOXANE, C13-14 ISOPARAFFIN, DIMETHICONE/VINYL DIMETHICONE CROSS POLYMER, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL STEARATE, HEXYLENE GLYCOL, ISOHEXADECANE, LAURETH-7 (COCONUT), PEG-100 STEARATE, PHENOXYETHANOL, POLYACRYLAMIDE, RETINYL PALMITATE (VITAMIN A), STEARYL ALCOHOL, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER.

* Please review the disclaimer below.