NUDESTIX DAILY MINERAL VEIL SPF 30 TINT - HOT- zinc oxide 15% lotion

Nudestix Daily Mineral Veil SPF 30 by

Drug Labeling and Warnings

Nudestix Daily Mineral Veil SPF 30 by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts / Info-Médicament

Active ingredient (w/w) / Ingrédient actif (p/p)

Zinc Oxide  15%

PURPOSE

Purpose / Utilite

Sun Protectant

INDICATIONS & USAGE

Uses / Usage Sunscreen Helps prevent sunburn Broad Spectrum (SPF 30)

UVA/UVB Protection If used as directed with other sun protection measures [see Directions

(for Use)], decreases the risk of skin cancer and early skin aging caused by the sun. /

Écran solaire Agent de protection solaire F.P.S. 30 à Large spectre Protection UVA/

UVB Si le produit est utilisé selon les instructions et avec d’autres mesures de protection

contre le soleil [voir les Mode d’emploi], le risque de cancer de la peau et de vieillissement

prématuré de la peau causé par le soleil est réduit.

WARNINGS

Warnings / Mises en garde
For external use only / Pour usage externe seulement

When using this product avoid contact with eyes. If contact occurs, rinse

thoroughly with water. / Lorsque vous utilisez ce produit éviter tout contact avec

les yeux. Le cas échéant, bien rincer avec de l’eau.

Stop use and consult a health care practitioner if rash occurs. / si une éruption

cutanée se développe.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, call a poison control centre or get

medical help right away. / En cas d’ingestion, appeler immédiatement un centre

antipoison ou obtenir une assistance médicale.

Do not use on damaged or broken skin/ sur une peau éraflée

DOSAGE & ADMINISTRATION

Directions / Mode d’emploi
Adults and children over 6 months. / Adultes et enfants de plus de 6 mois

Apply liberally/generously (and evenly) 15 minutes before sun exposure. / Appliquer

abondamment/généreusement (et uniformément) 15 minutes avant l’exposition au

soleil Reapply at least every 2 hours. / Appliquer de nouveau au moins toutes les 2

heures. Sun Protection Measures: Spending time in the sun increases your risk

of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen

with a Broad Spectrum SPF value of 15 or higher and other sun protection measures

including: limit time in the sun, especially from 10 a.m. - 2 p.m. / 11 a.m. - 3 p.m.

; and wear long-sleeved shirts, pants, hats, and sunglasses /Passer du temps au

soleil augmente le risque de cancer de la peau et du vieillissement prématuré de la

peau. Afin de diminuer ce risque, il convient d’utiliser régulièrement un écran solaire

avec un F.P.S. à large spectre d’au moins 15 et d’appliquer d’autres mesures de

protection contre le soleil, telles que : limiter le temps passé au soleil, notamment

entre 10h - 14h / 11h - 15h ; et porter des chemises à manches longues, des

pantalons, un chapeau et des lunettes de soleil. Test on a small area of skin

before first use. If irritation occurs (within 24 hours), use a different product. / Avant

d’utiliser, appliquer sur une petite surface de la peau. Si une irritation se produit

(dans un délai de 24 heures), utiliser une autre produit que celui-ci. Use a water

resistant sunscreen if swimming or sweating. / Utiliser un écran solaire résistant

à l’eau lors d’une activité aquatique ou s’il y a transpiration. Children under 6

months of age: ask a doctor / Enfants de moins de 6 mois : consulter un médecin

INACTIVE INGREDIENT

Inactive ingredients / Ingrédients inactifs
Aqua/Eau/Water, Coconut Alkanes, Caprylic/Capric Triglyceride, Propanediol,

Octyldodecanol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate,

Coco-Caprylate/Caprate, Methyl Dihydroabietate, Spirulina Platensis Extract,

C13-15 Alkane, Sodium Chloride, Iron Oxides (CI77492), Distarch Phosphate,

Iron Oxides (CI77491), Polyhydroxystearic Acid, Isostearic Acid, Quaternium-90

Bentonite, Hydroxyacetophenone, Benzyl Alcohol, 1,2-Hexanediol, Zinc

Stearate, Ethyl Ferulate, Iron Oxides (CI77499), Butylene Glycol, Mica (CI77019),

Triethyl Citrate, Iron Oxides(CI77491), Lactobacillus Ferment, Titanium Dioxide

(Ci77891), Passiflora Edulis Fruit Extract, Sorbitan Oleate, Camellia Sinensis

Leaf Extract

OTHER SAFETY INFORMATION

Other information/ Autres renseignements
Protect the product in this container from excessive heat and direct sun. /

Protégez le produit dans ce récipient de la chaleur excessive et du soleil direct.

QUESTIONS

Questions? www.nudestix.com Product of USA/Produit des USA

Principal Display Package - NUDESTIX™ DAILY MINERAL VEIL SPF 30 TINT: HOT

NUDESTIX™

NUDESCREEN

DAILY MINERAL VEIL

SPF 30

50 mL / 1.69 FL OZ US

TINT: HOT

MADE IN USE WITH GLOBALLY SOURCED COMPONENTS

IMPORTED BY NUDESTIX INC.

res

INGREDIENTS AND APPEARANCE

NUDESTIX DAILY MINERAL VEIL SPF 30  TINT - HOT
zinc oxide 15% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCONUT ALKANES (UNII: 1E5KJY107T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)
C13-15 ALKANE (UNII: 114P5I43UJ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DISTARCH PHOSPHATE, RICE (UNII: NS7M4Z5MSU)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOSTEARIC ACID (UNII: X33R8U0062)
QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ZINC STEARATE (UNII: H92E6QA4FV)
ETHYL FERULATE (UNII: 5B8915UELW)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MICA (UNII: V8A1AW0880)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PASSIFLORA EDULIS FRUIT (UNII: 602YE42W5R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-161-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2022

Labeler - Bentley Laboratories, LLC (068351753)