TROUVAILLE SUNSCREEN BROAD SPECTRUM SPF 30 UVA/UVB cream

Trouvaille Sunscreen Broad Spectrum SPF 30 UVA/UVB by

Drug Labeling and Warnings

Trouvaille Sunscreen Broad Spectrum SPF 30 UVA/UVB by is a Otc medication manufactured, distributed, or labeled by Monaesi Phytoceuticals, NATURAL TECHNOLOGY LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Zinc oxide

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”

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

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

NDC: 82285-020-01

Please see the attached image

Sunscreen

Broadspectrum

SPF 30

UVA/UVB

INGREDIENTS AND APPEARANCE

TROUVAILLE SUNSCREEN BROAD SPECTRUM SPF 30 UVA/UVB 
trouvaille sunscreen broad spectrum spf 30 uva/uvb cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82285-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)	7 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82285-120-01	20 in 1 BOX	05/15/2022
1		20 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/15/2022

Labeler - Monaesi Phytoceuticals (117831373)

Registrant - Monaesi Phytoceuticals (117831373)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL TECHNOLOGY LLC		618561906	manufacture(82285-120)