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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Drug Facts for Flawless by Sonya Aloe BB Creme - Nude 371

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 box

label for bb creme nude bottle

FLAWLESS BY SONYA ALOE BB CREME NUDE
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:11697-371
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	3.1500 g in 45.0000 g

Ingredient Name	Strength
Inactive Ingredients
WATER
DIMETHICONE
COCO-CAPRYLATE
MEDIUM-CHAIN TRIGLYCERIDES
TALC
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)
PROPANEDIOL
TITANIUM DIOXIDE
SORBITAN OLIVATE
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
STEARALKONIUM HECTORITE
MICA
SODIUM CHLORIDE
PHENOXYETHANOL
TROPOLONE
ALUMINUM OXIDE
TRIETHOXYCAPRYLYLSILANE
SODIUM DEHYDROACETATE
PROPYLENE CARBONATE
METHICONE (20 CST)
ALOE VERA LEAF
ACMELLA OLERACEA FLOWER
OLEA EUROPAEA BARK
ALUMINUM HYDROXIDE
STANNIC OXIDE
TRISODIUM ETHYLENEDIAMINE DISUCCINATE
ALCOHOL
MALTODEXTRIN
BLACK OLIVE

#	Item Code	Package Description
Packaging
1	NDC:11697-371-02	1 in 1 CARTON
1	NDC:11697-371-01	45 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2013

Labeler - Aloe Vera of America, Inc. (049049463)

Registrant - Aloe Vera of America, Inc. (049049463)

Name	Address	ID/FEI	Business Operations
Establishment
Aloe Vera of America, Inc.		049049463	manufacture(11697-371)

Revised: 4/2013

Document Id: 160eb344-1821-4964-9a6b-9f74d7fab335

Set id: 05d57c29-3d4e-45b9-9839-cd85712957ee

Version: 4

Effective Time: 20130416

Aloe Vera of America, Inc.