NDC 72688-103 Baby Mineral Sunscreen Roll-on Spf-50

Zinc Oxide

NDC Product Code 72688-103

NDC 72688-103-11

Package Description: 85 g in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Baby Mineral Sunscreen Roll-on Spf-50 with NDC 72688-103 is a a human over the counter drug product labeled by Project Sunscreen. The generic name of Baby Mineral Sunscreen Roll-on Spf-50 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Project Sunscreen

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Mineral Sunscreen Roll-on 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 18 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.

  • WATER (UNII: 059QF0KO0R)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCONUT ALKANES (UNII: 1E5KJY107T)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
  • CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • GALACTOARABINAN (UNII: SL4SX1O487)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)

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: Project Sunscreen
Labeler Code: 72688
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: 03-04-2019 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: 12-31-2020 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 Mineral Sunscreen Roll-on 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

Active Ingredient

ZINC OXIDE 18%

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 THE SUN.

Warnings

  • FOR EXTERNAL USE ONLYDO NOT USE ON DAMAGED OR BROKEN SKINWHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVESTOP USE AND ASK A DOCTOR IF RASH OCCURS

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCTS IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

  • SHAKE WELL BEFORE USEAPPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSUREREAPPLY: 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 VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:LIMIT TIME IN THE SUN, ESPECIALLY 10AM-2PMWEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSESCHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

Other Information

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

Inactive Ingredients

Water (Aqua), Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Glycerin, Coconut Alkanes, Coco-Caprylate/Caprate, Bis-Stearyl Dimethicone, Cetearyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Galactoarabinan, Niacinamide, Capryloyl Glycerin/Sebacic Acid Copolymer, Polyhydroxystearic Acid, Tocopheryl Acetate, Physalis Angulata Extract, Caprylic/Capric Triglycerides, 1,2-Hexanediol, Propanediol, Caprylhydroxamic Acid

Questions?

CALL 424.262.9462 OR VISIT PROJECTSUNSCREEN.COM

* Please review the disclaimer below.

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