FLAWLESS BY SONYA ALOE BB CREME SANDY- titanium dioxide cream

Flawless by Sonya Aloe BB Creme by

Drug Labeling and Warnings

Flawless by Sonya Aloe BB Creme by is a Otc medication manufactured, distributed, or labeled by Aloe Vera of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                Purpose
Titanium dioxide 7.04%.........................Sunscreen

PURPOSE

Uses

• helps prevent sunburn

WARNINGS

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

Do not use on damages or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

INSTRUCTIONS FOR USE

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 INGREDIENT

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

INDICATIONS & USAGE

Other information

• protect the product in the enclosed container from excessive heat and direct sun
• For your protection, this carton has a clear safety seal on both top and bottom flaps

QUESTIONS

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLAWLESS BY SONYA ALOE BB CREME  SANDY
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11697-372
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1680 g  in 45.0000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	18.8696 g  in 45.0000 g
DIMETHICONE (UNII: 92RU3N3Y1O)	4.5923 g  in 45.0000 g
COCO-CAPRYLATE (UNII: 4828G836N6)	2.9250 g  in 45.0000 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	2.8359 g  in 45.0000 g
TALC (UNII: 7SEV7J4R1U)	1.8630 g  in 45.0000 g
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)	1.7438 g  in 45.0000 g
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)	1.3500 g  in 45.0000 g
PROPANEDIOL (UNII: 5965N8W85T)	1.3500 g  in 45.0000 g
FERRIC OXIDE RED (UNII: 1K09F3G675)	0.3859 g  in 45.0000 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)	0.3859 g  in 45.0000 g
FERROSOFERRIC OXIDE (UNII: XM0M87F357)	0.3859 g  in 45.0000 g
SORBITAN OLIVATE (UNII: MDL271E3GR)	0.9000 g  in 45.0000 g
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE (UNII: 3Y9NJ5Z7E5)	0.9000 g  in 45.0000 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.4365 g  in 45.0000 g
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)	0.3375 g  in 45.0000 g
MICA (UNII: V8A1AW0880)	0.3195 g  in 45.0000 g
ALUMINUM OXIDE (UNII: LMI26O6933)	0.2340 g  in 45.0000 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.2250 g  in 45.0000 g
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)	0.1620 g  in 45.0000 g
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)	0.1350 g  in 45.0000 g
PROPYLENE CARBONATE (UNII: 8D08K3S51E)	0.1125 g  in 45.0000 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.0450 g  in 45.0000 g
ACMELLA OLERACEA FLOWER (UNII: 2794N5KM0K)	0.0441 g  in 45.0000 g
STANNIC OXIDE (UNII: KM7N50LOS6)	0.0315 g  in 45.0000 g
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)	0.0313 g  in 45.0000 g
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)	0.0167 g  in 45.0000 g
ALCOHOL (UNII: 3K9958V90M)	0.0135 g  in 45.0000 g
MALTODEXTRIN (UNII: 7CVR7L4A2D)	0.0135 g  in 45.0000 g
TROPOLONE (UNII: 7L6DL16P1T)	0.0135 g  in 45.0000 g
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)	0.0134 g  in 45.0000 g
BLACK OLIVE (UNII: 2M6QWV94OC)	0.0005 g  in 45.0000 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11697-372-02	1 in 1 CARTON
1	NDC: 11697-372-01	45 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2015

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Aloe Vera of America, Inc.		049049463	manufacture(11697-372)