Otc - Active Ingredient
Active Ingredient Purpose
Titanium dioxide 7.04%.........................Sunscreen
Flawless By Sonya Aloe Bb Creme
FDA Label NDC 11697-372
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 11697-372). 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, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - Do Not Use
Do not use on damages 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.
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
Otc - Questions
Questions or comments?
Call 1-888-440-2563, Monday-Friday, 9:00 am to 4:00 pm PT.
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