OTC Medication Information: Flawless by Sonya Aloe BB Creme Sandy

FLAWLESS BY SONYA ALOE BB CREME SANDY- 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.

Active Ingredient Purpose
Titanium dioxide 7.04%…………………….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 damages 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, 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.

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 or comments?

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3.1680 g in 45.0000 g
Inactive Ingredients
Ingredient Name Strength
WATER 18.8696 g in 45.0000 g
DIMETHICONE 4.5923 g in 45.0000 g
COCO-CAPRYLATE 2.9250 g in 45.0000 g
MEDIUM-CHAIN TRIGLYCERIDES 2.8359 g in 45.0000 g
TALC 1.8630 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
PROPANEDIOL 1.3500 g in 45.0000 g
FERRIC OXIDE RED 0.3859 g in 45.0000 g
FERRIC OXIDE YELLOW 0.3859 g in 45.0000 g
FERROSOFERRIC OXIDE 0.3859 g in 45.0000 g
SORBITAN OLIVATE 0.9000 g in 45.0000 g
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE 0.9000 g in 45.0000 g
PHENOXYETHANOL 0.4365 g in 45.0000 g
STEARALKONIUM HECTORITE 0.3375 g in 45.0000 g
MICA 0.3195 g in 45.0000 g
ALUMINUM OXIDE 0.2340 g in 45.0000 g
SODIUM CHLORIDE 0.2250 g in 45.0000 g
TRIETHOXYCAPRYLYLSILANE 0.1620 g in 45.0000 g
SODIUM DEHYDROACETATE 0.1350 g in 45.0000 g
PROPYLENE CARBONATE 0.1125 g in 45.0000 g
ALOE VERA LEAF 0.0450 g in 45.0000 g
ACMELLA OLERACEA FLOWER 0.0441 g in 45.0000 g
STANNIC OXIDE 0.0315 g in 45.0000 g
OLEA EUROPAEA LEAF 0.0313 g in 45.0000 g
TRISODIUM ETHYLENEDIAMINE DISUCCINATE 0.0167 g in 45.0000 g
ALCOHOL 0.0135 g in 45.0000 g
MALTODEXTRIN 0.0135 g in 45.0000 g
TROPOLONE 0.0135 g in 45.0000 g
ALUMINUM HYDROXIDE 0.0134 g in 45.0000 g
BLACK OLIVE 0.0005 g in 45.0000 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11697-372-02 1 TUBE in 1 CARTON contains a TUBE (11697-372-01)
1 NDC:11697-372-01 45 g in 1 TUBE This package is contained within the CARTON (11697-372-02)
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 Operations
Aloe Vera of America, Inc. 049049463 manufacture (11697-372)

Revised: 01/2015 Aloe Vera of America, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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