Aloette Medium CC Cream: Package Insert and Label Information

ALOETTE MEDIUM CC CREAM- octinoxate, homosalate and titanium dioxide cream
Aloette Cosmetics INC.

Aloette MEDIUM CC CREAM

Active Ingredient : Titanium Dioxide 10 % , Homosalate 10% , Octinoxate 7.5%

Purpose : Sunscreen

Do not use on damaged or broken Skin. Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children .

Inactive Ingredients : Aqua,C12-15 Alkyl Benzoate, Cetyl Alcohol,PEG-8,PPG-10 Butanediol, Propanediol , Glyceryl Stearate , PEG-100 Stearate , Triticum Vulgare (Wheat) Germ Extract , Butylene Glycol , Spiraea Ulmaria Extract , Hydrolyzed Ceratonia Siliqua Seed Extract, Xylitylglucoside , Anhydroxylitol , Xylitol , Hydroxyethyl Acrylate/Sodium Acrylodimethyl Taurate Copolymer , Isohexadecane , Polysorbate 60 ,Glycerin , Hydroxypropyl Cyclodextrin , Palmitoyl Tripeptide -38 , Niacinamide , Boron Nitride , Sodium Starch Octenylsuccinate , Lactic Acid , Butyrospermum Parkii (Shea Butter) , Retinol , Ceramide AP , Phenoxyethanol , Caprylyl Glycol , Sorbic Acid , Iron Oxide (CI 77491,CI 77492,CI77499)

For external use only.

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ALOETTE MEDIUM CC CREAM
octinoxate ,homosalate, titanium dioxide cream
Product Information
Product Type Item Code (Source) NDC:65447-375
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.25 g in 30 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 3 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3 g in 30 g
Inactive Ingredients
Ingredient Name Strength
WATER 38.29 g in 30 g
CETYL ALCOHOL 4.00 g in 30 g
C12-15 ALKYL BENZOATE 5.00 g in 30 g
PROPANEDIOL 2.50 g in 30 g
NIACINAMIDE 0.1 g in 30 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65447-375-00 30 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/10/2014
Labeler — Aloette Cosmetics INC. (831761320)

Revised: 04/2014 Aloette Cosmetics INC.

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