NDC 54473-164 Sun Shades Mineral Plus Sunscreen

NDC Product Code 54473-164

NDC CODE: 54473-164

Proprietary Name: Sun Shades Mineral Plus Sunscreen What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

NDC Code Structure

  • 54473 - Melaleuca, Inc.

NDC 54473-164-06

Package Description: 177 mL in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Sun Shades Mineral Plus Sunscreen with NDC 54473-164 is a product labeled by Melaleuca, Inc.. The product's dosage form is and is administered via form.

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.

  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • BIXA ORELLANA SEED (UNII: O87354RZ5A)
  • C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • KUKUI NUT OIL (UNII: TP11QR7B8R)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • MACADAMIA OIL (UNII: 515610SU8C)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • YELLOW WAX (UNII: 2ZA36H0S2V)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Melaleuca, Inc.
Labeler Code: 54473
Start Marketing Date: 05-01-2009 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

Sun Shades Mineral Plus Sunscreen Product Label Images

Sun Shades Mineral Plus 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

Otc - Active Ingredient

Active ingredientOctisalate 5%, Zinc oxide 10%

Otc - Purpose

PurposeSunscreen

Indications & Usage

  • Useshelps prevent sunburnhigher SPF gives more sunburn protectionfor skin highly sensitive to sunburnretains SPF after 80 minutes of activity in the water or sweating

Warnings

WarningsFor external use only

Otc - When Using

When using this product keep out of the eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash or irritation develops and lasts

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Directionsapply liberally and evenly to all exposed areas before sun exposurereapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.children under 6 months of age: ask a doctor

Inactive Ingredient

Inactive ingredientsaleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, caprylic/capric triglyceride, cera alba, cetearyl alcohol, ceteth-10 phosphate, cetyl alcohol, cetyl ethylhexanoate, dicaprylyl carbonate, dicetyl phosphate, disodium EDTA, disodium lauriminodipropionate tocopheryl phosphates, glycerin, hydrogenated palm glycerides, isoeicosane, isostearic acid, macadamia ternifolia seed oil, neopentyl glycol diheptanoate, parfum, pentylene glycol, phenoxyethanol, phenyl trimethicone, polyester-7, polyhydroxystearic acid, potassium cetyl phosphate, potassium sorbate, sodium chloride, sucrose distearate, tocopherol, triethanolamine, water, xanthan gum

* Please review the disclaimer below.