Label: NURIA DEFEND MATTE FINISH DAILY MOISTURIZER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide lotion
- NDC Code(s): 78611-4146-1
- Packager: Small World Brands
- 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 January 31, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- 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.
- Warnings
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Directions
- For sunscreen use:
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
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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 of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
- For sunscreen use:
- Other information
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Inactive ingredients
water, caprylic / capric triglyceride, glycerin, sorbitan laurate, isostearyl isostearate, polyglyceryl-4 laurate / succinate, decyl isostearate, citric acid, magnesium aluminum silicate, magnolia biondii bud / flower extract, melissa officinalis leaf extract, prunus persica flower extract, euphrasia officinalis extract, xanthan gum, aluminum stearate, alumina, isostearic acid, lecithin, butylene glycol, polyhydroxystearic acid, sodium benzoate, ethylhexylglycerin, phenoxyethanol
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 25 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
NURIA DEFEND MATTE FINISH DAILY MOISTURIZER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78611-4146 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 16.5 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 110 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) DECYL ISOSTEARATE (UNII: NRB038QC02) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) MAGNOLIA BIONDII FLOWER BUD (UNII: DZH9BOM6KD) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH) EUPHRASIA STRICTA (UNII: C9642I91WL) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM STEARATE (UNII: U6XF9NP8HM) ALUMINUM OXIDE (UNII: LMI26O6933) ISOSTEARIC ACID (UNII: X33R8U0062) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) SODIUM BENZOATE (UNII: OJ245FE5EU) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78611-4146-1 1 in 1 CARTON 03/15/2021 1 25 mL in 1 BOTTLE; 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 03/15/2021 Labeler - Small World Brands (104635996)