FLAWLESS BY SONYA ALOE BB CREME NUDE- titanium dioxide cream 
Aloe Vera of America, 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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Active Ingredient
Purpose
Titanium Dioxide 7%...............
Sunscreen

Uses

  • helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn not skin cancer or early skin aging.

For external use only



Do not use on damaged or broken skin


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

Stop use and ask a doctor if rash occurs



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

Directions

     
  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

Inactive Ingredientswater/aqua/eau, dimethicone, coco-caprylate, caprylic/capric triglyceride, talc, dimethicone/vinyl dimethicone crosspolymer, titanium dioxide (CI 77891), cetyl peg/ppg-10/1 dimethicone, propanediol, sorbitan olivate, glyceryl tribehenate/isostearate/eicosandioate, iron oxides (CI 77491, CI 77492, CI 77499), stearalkonium hectorite, mica, alumina, sodium chloride, phenoxyethanol, tropolone, triethoxycaprylylsilane, sodium dehydroacetate, propylene carbonate, hydrogen dimethicone, aloe barbadensis leaf extract, fragrance/parfum, spilanthes acmella flower extract, olea europaea (olive) leaf extract, aluminum hydroxide, tin oxide, trisodium ethylenediamine disuccinate, alcohol, maltodextrin, olea europaea (olive) fruit extract.

Other Information


  • protect the product in the enclosed container from excessive heat and direct sun

Questions or comments?Call 1-888-440-2563, Monday-Friday, 9:00 am to 4:00 pm PT.

label for bb creme nude

FLAWLESS BY SONYA ALOE BB CREME  NUDE
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11697-371
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE3.1500 g  in 45.0000 g
Inactive Ingredients
Ingredient NameStrength
WATER19.3196 g  in 45.0000 g
DIMETHICONE4.5923 g  in 45.0000 g
COCO-CAPRYLATE2.9250 g  in 45.0000 g
MEDIUM-CHAIN TRIGLYCERIDES2.8359 g  in 45.0000 g
TALC1.9506 g  in 45.0000 g
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)1.7438 g  in 45.0000 g
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)1.3500 g  in 45.0000 g
PROPANEDIOL1.3500 g  in 45.0000 g
TITANIUM DIOXIDE1.1686 g  in 45.0000 g
SORBITAN OLIVATE0.9000 g  in 45.0000 g
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE0.9000 g  in 45.0000 g
FERRIC OXIDE RED0.1001 g  in 45.0000 g
FERRIC OXIDE YELLOW0.4655 g  in 45.0000 g
FERROSOFERRIC OXIDE0.0558 g  in 45.0000 g
STEARALKONIUM HECTORITE0.3375 g  in 45.0000 g
MICA0.2565 g  in 45.0000 g
SODIUM CHLORIDE0.2250 g  in 45.0000 g
PHENOXYETHANOL0.2250 g  in 45.0000 g
TROPOLONE0.2250 g  in 45.0000 g
ALUMINUM OXIDE0.1620 g  in 45.0000 g
TRIETHOXYCAPRYLYLSILANE0.1620 g  in 45.0000 g
SODIUM DEHYDROACETATE0.1350 g  in 45.0000 g
PROPYLENE CARBONATE0.1125 g  in 45.0000 g
METHICONE (20 CST)0.0953 g  in 45.0000 g
ALOE VERA LEAF0.0450 g  in 45.0000 g
ACMELLA OLERACEA FLOWER0.0441 g  in 45.0000 g
OLEA EUROPAEA BARK0.0313 g  in 45.0000 g
ALUMINUM HYDROXIDE0.0252 g  in 45.0000 g
STANNIC OXIDE0.0225 g  in 45.0000 g
TRISODIUM ETHYLENEDIAMINE DISUCCINATE0.0167 g  in 45.0000 g
ALCOHOL0.0135 g  in 45.0000 g
MALTODEXTRIN0.0135 g  in 45.0000 g
BLACK OLIVE0.0005 g  in 45.0000 g
Packaging
#Item CodePackage Description
1NDC:11697-371-021 in 1 CARTON
1NDC:11697-371-0145 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2013
Labeler - Aloe Vera of America, Inc. (049049463)
Registrant - Aloe Vera of America, Inc. (049049463)
Establishment
NameAddressID/FEIBusiness Operations
Aloe Vera of America, Inc.049049463manufacture(11697-371)

Revised: 03/2013
Document Id: e13e308b-efb7-42d6-a412-71d1a4a5cdf7
Set id: 05d57c29-3d4e-45b9-9839-cd85712957ee
Version: 1
Effective Time: 20130307
 
Aloe Vera of America, Inc.