FLAWLESS BY SONYA ALOE BB CREME COCOA- 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 3%.....................................
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 Ingredients

water/aqua/eau, dimethicone, coco-caprylate, dimethicone/vinyl dimethicone crosspolymer, talc, iron oxides (CI 77491, CI 77492, CI 77499), caprylic/capric triglyceride, cetyl peg/ppg-10/1 dimethicone, propanediol, butylene glycol, sorbitan olivate, glyceryl tribehante/isostearate/eicosandioate, titanium dioxide (CI 77891), stearalkonium hectorite, mica, sodium chloride, phenoxyethanol, tropolone, sodium dehydroacetate, propylene carbonate, hydrogen dimethicone, alumina, enantia chlorantha bark extract, triethoxycaprylylsilane, aloe barbadensis leaf extract, fragrance/parfum, tin oxide, olea europaea (olive) leaf extract, trisodium ethylenediamine disuccinate, alcohol, maltodextrin, olea europaea (olive) fruit extract, oleanolic acid.

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.

cocoa bb creme label

FLAWLESS BY SONYA ALOE BB CREME  COCOA
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11697-373
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.3500 g  in 45.0000 g
Inactive Ingredients
Ingredient NameStrength
WATER18.4196 g  in 45.0000 g
DIMETHICONE4.7723 g  in 45.0000 g
COCO-CAPRYLATE2.9250 g  in 45.0000 g
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)2.4413 g  in 45.0000 g
TALC2.4255 g  in 45.0000 g
FERRIC OXIDE RED0.5909 g  in 45.0000 g
FERRIC OXIDE YELLOW1.5016 g  in 45.0000 g
FERROSOFERRIC OXIDE0.3330 g  in 45.0000 g
MEDIUM-CHAIN TRIGLYCERIDES1.9800 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
BUTYLENE GLYCOL1.2821 g  in 45.0000 g
SORBITAN OLIVATE0.9000 g  in 45.0000 g
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE0.9000 g  in 45.0000 g
TITANIUM DIOXIDE0.3870 g  in 45.0000 g
STEARALKONIUM HECTORITE0.3375 g  in 45.0000 g
MICA0.3195 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
SODIUM DEHYDROACETATE0.1350 g  in 45.0000 g
PROPYLENE CARBONATE0.1125 g  in 45.0000 g
METHICONE (20 CST)0.0990 g  in 45.0000 g
ALUMINUM OXIDE0.0878 g  in 45.0000 g
ANNICKIA CHLORANTHA BARK0.0675 g  in 45.0000 g
TRIETHOXYCAPRYLYLSILANE0.0608 g  in 45.0000 g
ALOE VERA LEAF0.0450 g  in 45.0000 g
STANNIC OXIDE0.0315 g  in 45.0000 g
OLEA EUROPAEA BARK0.0313 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
OLEANOLIC ACID0.0004 g  in 45.0000 g
Packaging
#Item CodePackage Description
1NDC:11697-373-021 in 1 CARTON
1NDC:11697-373-0145 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(11697-373)

Revised: 03/2013
Document Id: df85f9c3-3ba1-4a8b-976c-db2563171f89
Set id: 7c801162-6c8e-4c6c-b8ff-91fb06cd2ca3
Version: 1
Effective Time: 20130308
 
Aloe Vera of America, Inc.