NDC 79753-009 Baby Bare Republic Mineral Sunscreen Softstick Spf 50

Zinc Oxide

NDC Product Code 79753-009

NDC 79753-009-01

Package Description: 1 CANISTER in 1 BLISTER PACK > 25 g in 1 CANISTER

NDC Product Information

Baby Bare Republic Mineral Sunscreen Softstick Spf 50 with NDC 79753-009 is a a human over the counter drug product labeled by Coola Llc. The generic name of Baby Bare Republic Mineral Sunscreen Softstick Spf 50 is zinc oxide. 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 Softstick Spf 50 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 17.9 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.

  • SHEA BUTTER (UNII: K49155WL9Y)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS (UNII: R2Z4507WJN)
  • CHAMOMILE (UNII: FGL3685T2X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYL FERULATE (UNII: 5B8915UELW)
  • COTTONSEED OIL (UNII: H3E878020N)
  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
  • ISODODECANE (UNII: A8289P68Y2)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • 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: 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 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: 03-03-2021 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.

Baby Bare Republic Mineral Sunscreen Softstick Spf 50 Product Label Images

Baby Bare Republic Mineral Sunscreen Softstick Spf 50 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

Drug FactsActive IngredientsZinc Oxide 17.9%

Otc - Purpose

PurposeSuncreen

Indications & Usage

Uses • 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

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

Otc - Stop Use

Stop use and ask 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.

Dosage & Administration

Directions• Apply liberally 15 minutes before sun exposure.• reapply:  ● after 80 minutes of swimming or sweating   ● immediately after towel drying    ● at least every 2 hours●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 spection SPF of 15 or higher and other sun protectionmeasures including: SPF of 15 or higher and other sun protection● limit time in the sun, especially from: 10 a.m. - 2 p.m.● wear long-sleeve shirts, pants, hats, and sunglasses●Children under 6 months: Ask a doctor

Inactive Ingredient

Inactive IngredientsButyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethyl Ferulate, Gossypium Herbaceum (Cotton) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Isododecane, Neopentyl Glycol Diheptanoate, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Stearyl Alcohol, Tocopherol, Triethoxycaprylylsilane

Other Safety Information

  • Other informationprotect this product from excessive heat and direct sun

Other

Questions or comments?Call 760-940-2125

Coola Label

BABY BAREREPUBLICMINERAL SUNSCREENSoftstick0.9 OZ / 25 g*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & CoolSan Diego, CA 92010. All Rights Reserved.WWW.GOBAREOUTSIDE.COMres

* Please review the disclaimer below.