Flawless By Sonya Aloe Bb Creme
FDA Label NDC 11697-373

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aloe Vera Of America, Inc. for the product Flawless By Sonya Aloe Bb Creme (NDC 11697-373). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient


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

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

Otc - Do Not Use

Do not use on damaged or broken skin


Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - 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.



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, 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

Otc - Questions

Questions or comments?

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

* Please review the disclaimer below.