NDC 70157-007 Premium Natural Sunscreen Broad Spectrum Spf 30 Baby Bum

Zinc Oxide

NDC Product Code 70157-007

NDC 70157-007-02

Package Description: 1 CYLINDER in 1 CARTON > 13 g in 1 CYLINDER (70157-007-01)

NDC Product Information

Premium Natural Sunscreen Broad Spectrum Spf 30 Baby Bum with NDC 70157-007 is a a human over the counter drug product labeled by Baxter Laberatories. The generic name of Premium Natural Sunscreen Broad Spectrum Spf 30 Baby Bum is zinc oxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Baxter Laberatories

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Premium Natural Sunscreen Broad Spectrum Spf 30 Baby Bum 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 20 g/100g

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.

  • SHEANUT OIL (UNII: O88E196QRF)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Baxter Laberatories
Labeler Code: 70157
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: 04-27-2015 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.

Premium Natural Sunscreen Broad Spectrum Spf 30 Baby Bum Product Label Images

Premium Natural Sunscreen Broad Spectrum Spf 30 Baby Bum 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

Active Ingredients         PurposeZinc Oxide 20%   ........... Sunscreen

Otc - Purpose

  • UsesHelps 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

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Stop used and ask a doctor if rash occurs

Warnings

WarningsFor external use onlyDo not use on damaged or broken skinWhen using this Product: Keep out of eyes. Rinse with water to remove

Dosage & Administration

  • DirectionsApply liberally 15 minutes before sun exposureReapply: After 80 minutes of swimming or sweating Immediately after towel dryingAt least every2 hoursSun 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 of 15 or higher and other sun protection measures, including:Limit time in the sun, especially form 10 am - 2 pm.Wear long-sleeve shirts, pants, hats, and sunglassesChildren under 6 months: Ask a doctor

Inactive Ingredient

Inactive IngredientsButyrospermum Parkii (shea) Butter, Caprylic/Capric Triglyceride, Cera Alba, Copernicia Cerifer(Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Blyceryl Isostearate, Polyhydroxystearic Acid, Parfum, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ricinus Communis (Castor) Seed Oil, Tocopherol

* Please review the disclaimer below.