NDC 76354-478 Well People Bio Tint Spf 30 Sunscreen 13w

Zinc Oxide

NDC Product Code 76354-478

NDC 76354-478-01

Package Description: 1 BOTTLE in 1 BOX > 35.5 mL in 1 BOTTLE

NDC Product Information

Well People Bio Tint Spf 30 Sunscreen 13w with NDC 76354-478 is a a human over the counter drug product labeled by J.a. Cosmetics U.s. Inc. The generic name of Well People Bio Tint Spf 30 Sunscreen 13w is zinc oxide. 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.

Well People Bio Tint Spf 30 Sunscreen 13w 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.

  • WATER (UNII: 059QF0KO0R)
  • COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
  • POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • JOJOBA OIL (UNII: 724GKU717M)
  • RASPBERRY SEED OIL (UNII: 9S8867952A)
  • ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP)
  • CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
  • BROCCOLI SEED OIL (UNII: SY01LVD4G4)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
  • GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
  • CALCIUM GLUCONATE (UNII: SQE6VB453K)
  • FYTIC ACID (UNII: 7IGF0S7R8I)

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: J.a. Cosmetics U.s. Inc
Labeler Code: 76354
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: 09-01-2021 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: 12-31-2022 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.

Well People Bio Tint Spf 30 Sunscreen 13w Product Label Images

Well People Bio Tint Spf 30 Sunscreen 13w 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

Zinc Oxide 20%

Purpose

Sunscreen

Use

  • 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.

Warning

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 exposure. Reapply at least every 2 hours.Use 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 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 sun, especially from 10 a.m.-2 p.m., wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: ask a doctor.

Other Information

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

Inactive Ingredients

Water (Aqua), Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Glycerin, Triethylhexanoin, Butyloctyl Salicylate, Butylene Glycol Dicaprylate/Dicaprate, Caprylic/Capric Triglyceride, Polyglyceryl-4 Isostearate, Magnesium Sulfate, Disteardimonium Hectorite, Shea Butter Ethyl Esters, Polyhydoxystearic Acid, Lecithin, Isostearic Acid, Gluconolactone, Cocos Nucifera (Coconut) Oil/Cocos Nucifera Oil*, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil/ Helianthus Annuus Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil/ Simmondsia Chinensis Seed Oil*, Rubus Idaeus (Raspberry) Seed Oil/ Rubus Idaeus Seed Oil, Rosa Rubiginosa Seed Oil, Hippophase Rhamnoides (Sea Buckthorn) Oil/Hippophae Rhamnoides Oil, Crambe Abyssinica Seed Oil, Brassica Oleracea Italica (Broccoli) Seed Oil/ Brasica Oleracea Italica Oil, Aloe Barbadensis (Aloe) Leaf Juice/Aloe Barbadensis Leaf Juice, Maltodextrin, Potassium Sorbate, Glyceryl Caprylate, Sodium Benzoate, Isopropyl Titanium Triisostearate, Glyceryl Undecylenate, Calcium Gluconate, Phytic Acid MAY CONTAIN: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) *Organic Ingredients

* Please review the disclaimer below.