Label: NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDE- zinc oxide lotion
- NDC Code(s): 54111-167-50
- Packager: Bentley Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 17, 2023
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- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses / Usages • Sun Protection Factor 30 • Sunscreen • Helps prevent
sunburn • Broad Spectrum (SPF 30) • UVA/UVB Protection • If used as directed
with other sun protection measures [see Directions], decreases the risk of skin cancer
and early skin aging caused by the sun./ • Facteur de protection solaire 30 • Crème solaire
• Aide à prévenir les coups de soleil • F.P.S. 30 à Large spectre • Protection UVA/UVB • Sile
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
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 les yeux..Stop use and consult a health care practitioner if rash occurs. /Arrêter
l’utilisation et consultez un professionnel de la santé en cas d’éruption cutanée - KEEP OUT OF REACH OF CHILDREN
- DO NOT USE
-
DOSAGE & ADMINISTRATION
Directions / Mode d’emploi
• Adults and children over 6 months. • Apply generously and evenly 15 minutes before sun exposure. • Reapply at least every 2 hours. / • Adultes et enfants de plus de 6 mois • Appliquer abondamment/généreusement (et uniformément) 15 minutes avant l’exposition au soleil • 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. • Wear long-sleeved shirts, pants, hats, and sunglasses • Test on a small area of skin before first use. If irritation occurs (within 24 hours), use a different product • Use a water-resistant sunscreen if swimming or sweating • Children under 6 months of age: ask a doctor / Mesures de protection solaire: 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 • Porter des chemises à manches longues, des pantalons, un chapeau et des lunettes de soleil. • 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. • Utiliser un écran solaire résistant à l’eau lors d’une activité aquatique ou s’il y a transpiration. • Enfants de moins de 6 mois: consulter un médecin -
INACTIVE INGREDIENT
Inactive ingredients / Ingrédients inactifs
Aqua/Water/Eau, Coconut Alkanes, Caprylic/Capric Triglyceride, Propanediol,
Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Coco-Caprylate/
Caprate, Methyl Dihydroabietate, Spirulina Platensis Extract, C13-15 Alkane,
Sodium Chloride, Octyldodecanol, Distarch Phosphate, Isostearic Acid,
Polyhydroxystearic Acid, Iron Oxides (CI 77492), Quaternium-90 Bentonite,
1,2-Hexanediol, Benzyl Alcohol, Hydroxyacetophenone, Zinc Stearate, Ethyl
Ferulate, Iron Oxides (CI 77491), Butylene Glycol, Triethyl Citrate, Mica,
Iron Oxides (CI 77499), Passiflora Edulis Fruit Extract, Titanium Dioxide (CI 77891),
Sorbitan Oleate, Camellia Sinensis Leaf Extract - OTHER SAFETY INFORMATION
- QUESTIONS
- Principal Display Package - NUDESTIX™NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT: NUDE
-
INGREDIENTS AND APPEARANCE
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDE
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-167 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) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE) C13-15 ALKANE (UNII: 114P5I43UJ) SODIUM CHLORIDE (UNII: 451W47IQ8X) OCTYLDODECANOL (UNII: 461N1O614Y) DISTARCH PHOSPHATE, CORN (UNII: JFB4DJZ8BR) ISOSTEARIC ACID (UNII: X33R8U0062) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) BENZYL ALCOHOL (UNII: LKG8494WBH) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ZINC STEARATE (UNII: H92E6QA4FV) ETHYL FERULATE (UNII: 5B8915UELW) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) MICA (UNII: V8A1AW0880) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PASSIFLORA EDULIS FRUIT (UNII: 602YE42W5R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54111-167-50 1 in 1 CARTON 02/12/2023 1 50 mL 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 part347 02/12/2023 Labeler - Bentley Laboratories, LLC (068351753)