Label: NOEVIR RAYSELA UV SHIELD PRIMER- zinc oxide, octinoxate cream
- NDC Code(s): 24509-0001-1
- Packager: Nippon Shikizai, Inc.
- 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 7, 2021
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
Protects skins from the sun's harmful rays (UV-A, UV-B) to prevent sunburn, spots and premature signs of aging while keeping your skin hydrated.
- Broad Spectrum SPF50+ effectively shields UV rays while hydrating skin.
- Can be used as a makeup base throughout the year.
- Light-diffusing emulsion creates soft and smoother appearance.
- Deeply moisturizing without heaviness for youthful looking skin.
- Specially formulated emulsion provided light, pleasant finish while absorbing excess sebum.
Drug Facts
- Active Ingredients
- Purpose
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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.
- reapply at least every 2 hours.
- use a water-resistant sunscreen if swimming or sweating.
- 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.
- Other Information
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Inactive ingredients
WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, DIPHENYLSILOXY PHENYL TRIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, DISTEARDIMONIUM HECTORITE, HYDROGEN DIMETHICONE, PENTYLENE GLYCOL, GLYCERIN, MAGNESIUM SULFATE, POLYHYDROXYSTEARIC ACID, SORBITAN SESQUIISOSTEARATE, TRIMETHYLSILOXYSILICATE, SILICA DIMETHYL SILYLATE, SODIUM CITRATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TOCOPHEROL, SQUALANE, ALCOHOL, CELLULOSE ACETATE, ASCOPHYLLUM NODOSUM EXTRACT, SORBITOL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, PHELLODENDRON AMURENSE BARK EXRACT, BELAMCANDA CHINENSIS ROOT EXTRACT, VITIS VINIFERA (GRAPE) LEAF EXTRACT, CITRUS GRANDIS (GRAPEFRUIT) FRUIT EXTRACT, SPIRAEA ULMARIA FLOWER EXTRACT, PHENOXYETHANOL, FRAGRANCE
- Principal Display Panel - Raysela UV Shield Primer Label
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INGREDIENTS AND APPEARANCE
NOEVIR RAYSELA UV SHIELD PRIMER
zinc oxide, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24509-0001 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 176.7 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 69.9 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SQUALANE (UNII: GW89575KF9) TOCOPHEROL (UNII: R0ZB2556P8) CELLULOSE ACETATE (UNII: 3J2P07GVB6) ROSEMARY (UNII: IJ67X351P9) ALCOHOL (UNII: 3K9958V90M) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) PUMMELO (UNII: ET1TN5W71X) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) IRIS DOMESTICA ROOT (UNII: T2MU9QFA87) VITIS VINIFERA LEAF (UNII: R1H893D80E) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) SORBITOL (UNII: 506T60A25R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24509-0001-1 1 in 1 BOX 04/10/2018 1 50 g 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 04/10/2018 Labeler - Nippon Shikizai, Inc. (692572936) Establishment Name Address ID/FEI Business Operations Nippon Shikizai, Inc. 692076308 MANUFACTURE(24509-0001) , ANALYSIS(24509-0001) , PACK(24509-0001) , LABEL(24509-0001)
