SPF 15 FAIR- titanium dioxide powder

SPF 15 by

Drug Labeling and Warnings

SPF 15 by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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.

CLINICAL STUDIES

Other Information

• dermatologist and allergy tested
  

STORAGE AND HANDLING

Other Information

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

INACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENT

Active Ingredient               Purpose

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

INGREDIENTS AND APPEARANCE

SPF 15  FAIR
titanium dioxide powder

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Melaleuca, Inc. (139760102)