Label: NUDESTIX DAILY MINERAL VEIL SPF 30 TINT - HOT- zinc oxide 15% lotion
- NDC Code(s): 54111-161-50
- Packager: Bentley Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2023
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- ACTIVE INGREDIENT
- PURPOSE
-
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 seulementWhen 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
-
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
- QUESTIONS
- Principal Display Package - NUDESTIX™ DAILY MINERAL VEIL SPF 30 TINT: HOT
-
INGREDIENTS AND APPEARANCE
NUDESTIX DAILY MINERAL VEIL SPF 30 TINT - HOT
zinc oxide 15% lotionProduct 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)