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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Drug Facts for Flawless by Sonya Aloe BB Creme - Cocoa 373


Active Ingredient
Purpose
Titanium dioxide 3%.....................................
Sunscreen

Uses

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

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


Questions or comments?

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

cocoa bb creme box

cocoa bb creme tube

FLAWLESS BY SONYA ALOE BB CREME  COCOA
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11697-373
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.3500 g  in 45.0000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)  
PROPANEDIOL (UNII: 5965N8W85T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE (UNII: 3Y9NJ5Z7E5)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
MICA (UNII: V8A1AW0880)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TROPOLONE (UNII: 7L6DL16P1T)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
OLEA EUROPAEA BARK (UNII: 4BN4L34UKC)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
ALCOHOL (UNII: 3K9958V90M)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
BLACK OLIVE (UNII: 2M6QWV94OC)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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: 1/2014
Document Id: 40f0d8fc-d934-4156-8f49-7ec4e266c6b6
Set id: 7c801162-6c8e-4c6c-b8ff-91fb06cd2ca3
Version: 6
Effective Time: 20140113
 
Aloe Vera of America, Inc.