NDC 79753-003 Baby Bare Republic Mineral Sunscreen

Zinc Oxide 24%

NDC Product Code 79753-003

NDC Product Information

Baby Bare Republic Mineral Sunscreen with NDC 79753-003 is a a human over the counter drug product labeled by Coola, Llc. The generic name of Baby Bare Republic Mineral Sunscreen is zinc oxide 24%. The product's dosage form is stick and is administered via topical form.

Labeler Name: Coola, Llc

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.

Baby Bare Republic Mineral 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 24 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.

  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CERESIN (UNII: Q1LS2UJO3A)
  • CHAMOMILE (UNII: FGL3685T2X)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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: Coola, Llc
Labeler Code: 79753
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: 10-28-2020 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.

Baby Bare Republic Mineral Sunscreen Product Label Images

Baby Bare Republic Mineral 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 Ingredient

Zinc Oxide 25%

Purpose

Zinc Oxide 25%.........Sunscreen

Uses

  • Helps prevent sunburnif used as directed with other sun protection methods (see
  • Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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. Rinse with water to remove

Otc - Stop Use

Stop use and ask a doctor if skin rash occurs

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.

Directions

  • Apply liberally for 15 minutes before sun exposure
  • Reapply:
  • After 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 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 from 10a.m. - 2p.m.wear long sleeve shirts, pants, hats and sunglasseschildren under 6 months: ask a doctor.

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Extract, Buyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorious (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Euphorbia Cerifera (Candelilla) Was, Helianthus Annuus (Sunflower) Seed Oil, Olea Europea (Olive) Fruit Oil, Ozokerite, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Therobroma Cacao (Cocoa) Seed Butter, Tocopherol, Triethoxycaprylylsilane

Other Information

  • May stain fabricsprotect this product from excessive heat and direct sun

* Please review the disclaimer below.