SPF 15 Medium

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 0.7g in 10g
Labeler: Melaleuca, Inc.
NDC Code: 54473-176

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Label of Mineral Foundation Medium

Directions

Apply evenly before sun exposure and as needed. Gently swirl your Sei Bella Brush across the top and tap to remove excess.
Make sure powder is evenly distributed on brush before applying to face. Blend foundation to the desired level of coverage.

Other Information

  • dermatologist and allergy tested

Other Information

  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Inactive Ingredients

Mica (CI77019), Bismuth Oxichloride (CI 77163), Nylon-12, C12-15 Alkyl Benzoate, Phenoxyethanol, Kaolin, Silica Dimethyl Silylate, Ascorbyl Palmitate, Chlorphensin, Potassium Sorbate, Retinyl Palmitate, Lecithin, Hyaluronic Acid (and) Echinacin, Glycerin (and) Water (and) Urea (and) Trehalose (and) Polyquaternium-51 (and) Triacetin (and) Sodium Hyaluronate, Zinc PCA, Lauryl PCA, Dimethicone (and) Water (and) Silica Dimethyl Silylate (and) Atelocollagen (and) Lysine HCI (and) Glycine (and) Sodium Chondrotin Sulfate (and) Ornithine HCI, Zinc Oxide, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 2, 9)

Active ingredients               Purpose

Titanium Dioxide.............Sunscreen

SPF 15  MEDIUM
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-176
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.7 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
MICA 
BISMUTH OXYCHLORIDE 
PHENOXYETHANOL 
KAOLIN 
ASCORBYL PALMITATE 
CHLORPHENESIN 
POTASSIUM SORBATE 
VITAMIN A PALMITATE 
LECITHIN, SOYBEAN 
HYALURONIC ACID 
GLYCERIN 
WATER 
UREA 
TREHALOSE 
TRIACETIN 
DIMETHICONE 
LYSINE HYDROCHLORIDE 
GLYCINE 
CHONDROITIN SULFATE (PORCINE) 
ZINC OXIDE 
TITANIUM DIOXIDE 
ALPHA-TOCOPHEROL ACETATE 
C12-15 ALKYL BENZOATE 
SODIUM PYRROLIDONE CARBOXYLATE 
HYALURONATE SODIUM 
ORNITHINE HYDROCHLORIDE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
ZINC PIDOLATE 
SILICON DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:54473-176-0110 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/15/2010
Labeler - Melaleuca, Inc. (139760102)

Revised: 12/2010
 
Melaleuca, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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