Active Ingredient(S)
Zinc oxide
Trouvaille Sunscreen Broad Spectrum Spf 30 Uva/uvb
FDA Label NDC 82285-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Monaesi Phytoceuticals for the product Trouvaille Sunscreen Broad Spectrum Spf 30 Uva/uvb (NDC 82285-120). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
sunscreen
Use
helps prevent sunburn”
Warnings
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”
For sunscreen drug products that do not pass the Broad Spectrum Test or that have SPF values less than 15, the first statement under Warnings must be:
“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 help prevent sunburn, not skin cancer or early skin aging.”
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
Other Information
“protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Water, Coco-Caprylate/Caprate, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Jojoba Esters, Sylibum Marianum Ethyl Ether, Gum Arabica, Cetyl Palmitate, Sorbitan Palmitate, Sorbitan Olivate, Inulin, Tetrahexyldecyl Ascorbate, Crocus Chrysanthus Bulb Extract, Hedychium Coronarium Root Extract, Fructooligosaccharides, Punica Granatum Fruit Extract, Beta Vulgaris(beet) Root Extract, Ficus Carica (fig) Fruit Extract, Glyceryl Stearate, Tocopherol, Morus Alba Fruit Extracf, Ginkgo Biloba Nut Extract, Potassium Lactate, Lactic Acid, Triethoxycaprylylsilane, Polyhydroxystearate Acid, Sclerotium Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pullulan, Lecithin, Silica, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Glyceryl Caprylate, Nitrilotriacetic Acid Trisodium Salt, Propanediol, Polysorbate-60, Sorbitan Isostearate
Package Label - Principal Display Panel
Sunscreen (D7fd07ae Cc15 69b8 E053 2995a90a40a5)
Please see the attached image
Sunscreen
Broadspectrum
SPF 30
UVA/UVB
* Please review the disclaimer below.
