Label of Mineral Foundation Fair

SPF 15 FAIR- titanium dioxide powder
Melaleuca, Inc.

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.

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Directions

Apply evenly before sun exposure and as needed. Gently swirl your Sei Bella Brush across the tip 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 (CI 77019), Bismuth Oxichloride (CI 77163), Nylon-12, C12-15 Alkyl Benzoate, Phenoxyethanol, Kaolin, Silica Dimethyl Silylate, Ascorbyl Palmitate, Chlorphensin, Potassium Sorbate, Retinly 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 Silicylate (and) Atelocollagen (and) Lysine HCI (and) Glycine (and) Sodium Chrondrotin Sulfate (and) Ornithine HCI, Zinc Oxide, Titanium Oxide (CI 778914), Iron Oxides (CI 77491, 2, 9)

image of label

Active Ingredient Purpose

Titanium Dioxide 7%.......Sunscreen

SPF 15 FAIR
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54473-174
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.7 g in 10 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
KAOLIN (UNII: 24H4NWX5CO)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CHLORPHENESIN (UNII: I670DAL4SZ)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
UREA (UNII: 8W8T17847W)
TREHALOSE (UNII: B8WCK70T7I)
TRIACETIN (UNII: XHX3C3X673)
DIMETHICONE (UNII: 92RU3N3Y1O)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
GLYCINE (UNII: TE7660XO1C)
CHONDROITIN SULFATE (PORCINE) (UNII: V5E8ELO4W9)
ZINC OXIDE (UNII: SOI2LOH54Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ORNITHINE HYDROCHLORIDE (UNII: HBK84K66XH)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC PIDOLATE (UNII: C32PQ86DH4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54473-174-01	10 g in 1 CONTAINER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	09/15/2010

Labeler - Melaleuca, Inc. (139760102)