NDC 15751-3503 Eminence Bright Skin Moisturizer Spf 40 Sunscreen

Zinc Oxide

NDC Product Code 15751-3503

NDC 15751-3503-1

Package Description: 1 JAR in 1 BOX > 60 mL in 1 JAR

NDC 15751-3503-2

Package Description: 1 JAR in 1 BOX > 250 mL in 1 JAR

NDC Product Information

Eminence Bright Skin Moisturizer Spf 40 Sunscreen with NDC 15751-3503 is a a human over the counter drug product labeled by Eminence Organic Skin Care. The generic name of Eminence Bright Skin Moisturizer Spf 40 Sunscreen is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Eminence Organic Skin Care

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.

Eminence Bright Skin Moisturizer Spf 40 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.

  • 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • LEMON (UNII: 24RS0A988O)
  • CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
  • MENTHA PIPERITA LEAF (UNII: A389O33LX6)
  • ROSEMARY (UNII: IJ67X351P9)
  • SAGE (UNII: 065C5D077J)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
  • COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
  • PRIMULA VERIS WHOLE (UNII: W6LFQ57E4M)
  • ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)
  • MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
  • ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • SORBIC ACID (UNII: X045WJ989B)
  • CHLOROPHYLL (UNII: 00WNZ48OR9)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • ACAI (UNII: 46AM2VJ0AW)
  • CARROT (UNII: L56Z1JK48B)
  • COCONUT WATER (UNII: 267F5Y81NT)
  • STARCH, TAPIOCA (UNII: 24SC3U704I)
  • THIOCTIC ACID (UNII: 73Y7P0K73Y)
  • UBIDECARENONE (UNII: EJ27X76M46)

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: Eminence Organic Skin Care
Labeler Code: 15751
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: 01-01-2021 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: 12-31-2021 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.

Eminence Bright Skin Moisturizer Spf 40 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

Active Ingredients

Zinc Oxide 20%

Purpose

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 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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposureReapply 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 of age: Ask a doctor

Other Information

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

Inactive Ingredients

Organic Phytonutrient Blend [Aloe Barbadensis (Aloe) Juice, Glycyrrhiza Glabra (Licorice) Root Extract*, Citrus Limon (Lemon) Peel Extract*, Cymbopogon Schoenanthus (Lemongrass) Extract*, Salix Alba (Willow) Bark Extract*, Arctostaphylos Uva Ursi (Bearberry) Leaf Extract*, Mentha Piperita (Peppermint) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Salvia Officinalis (Sage) Extract*, and Vegetable Glycerin], Persea Gratissima (Avocado) Oil*, Hypoxis Rooperi (African Potato) Extract, Vegetable Glycerin*, Aloe Barbadensis (Aloe) Juice*, Butyrospermum Parkii (Shea Butter)*, Cetearyl Alcohol, Sodium Cetearyl Sulfate, Coco Caprylate/Caprate, Sempervivum Tectorum (Stone Crop) Extract*, Glyceryl Stearate, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Panthenol (Provitamin B5), Sodium Hyaluronate (Botanical Hyaluronic Acid), Hydrolyzed Caesalpinia Spinosa (Tara Tree) Gum, Com-Derived Methyl Glucose Sesquistearate, Soy Lecithin, Polyhydroxystaric Acid, Xanthan Gum, Lactic Acid, Ascorbyl Palmitate (Vitamin C Ester), Citrus Limon (Lemon) Oil, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Chlorophyl, Sodium Benzoate, Potassium Sorbate, Sodium Phytate, Sodium PCA, Blocomplex2 (Euterpe Oleracea (Acai)*, Citrus Limon (Lemon)*, Malpighia Glabra (Barbados Cherry)*, Embica Officinalis (Indian Gooseberry)*, Adansonia Digitata (Baobab)*, Myrciaria Dubia (Camu Camu)*, Daucus Carota Sativa (Carrot)*, Cocos Nucifera (Coconut) Water*, Lycium Barbarum (Goji) Berry*, Tapioca Starch (from Cassava Root)*, Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10)].


*Certified organic ingredient

Note

Store in controlled temperatures (4–20°C/39–68°F). Keep in a dark and dry place. Keep container tightly closed. Do not use if seal under cap is broken or missing.

* Please review the disclaimer below.