Label: EMINENCE RADIANT PROTECTION SPF FLUID- zinc oxide liquid
- NDC Code(s): 15751-3506-1
- Packager: Eminence Organic Skin Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 July 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Radiant Protection SPF Fluid
Drug Facts
Active Ingredient Purpose
Zinc Oxide 15%……………………...Sunscreen
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 sunWarnings
For external use only
Do not use
on damaged or broken skin
When using this product
keep out of eyes. Rinse with water to remove
Stop use and ask doctor if
rash occurs
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Shake well before 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 value 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-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months of age: Ask a doctor.Other information
Protect the product in this container from excessive heat and direct sun.
Inactive ingredients
Caprylic/Capric Triglyceride*, Butyloctyl Salicylate, Oryza Sativa (Rice) Wax*, Copernicia Cerifera (Carnauba) Wax*, Triheptanoin, Pentaerythrityl Stearate/Caprate/Caprylate/Adipate, Polyhydroxystearic Acid, Lauroyl Lysine, Methyl Glucose Dioleate, Hydrogenated Poly(C6-20 Olefin),
HDI/Trimethylol Hexyllactone Crosspolymer, Niacinamide (Vitamin B3), C13-16 Isoalkane, Bakuchiol, Natural Fragrance, Biocomplex2™ [Daucus Carota Sativa (Carrot) Seed Oil*, Euterpe Oleracea (Acai) Fruit Extract*, Citrus Limon (Lemon) Juice*, Malpighia Glabra (Barbados Cherry) Fruit Extract*, Emblica Officinalis (Indian Gooseberry) Fruit Extract*, Adansonia Digitata (Baobab) Fruit Extract*, Myrciaria Dubia (Camu Camu) Fruit Extract*, Daucus Carota Sativa (Carrot) Root Extract*, Cocos Nucifera (Coconut) Water*, Lycium Barbarum (Goji) Fruit Extract*, Helianthus Annuus (Sunflower) Seed Oil*, Plant-Derived Maltodextrin* and Vegetable Glycerin*].
DISTRIBUTED BY
Éminence Organic Skin Care
#300 - 530 West Broadway, Vancouver BC V5Z 1E9
www.eminenceorganics.com
1-888-747-6342 (US & Canada Toll Free)
FORMULATED IN HUNGARY / Made in USA
Refer to Radiant Protection SPF Fluid US 1.7oz
-
INGREDIENTS AND APPEARANCE
EMINENCE RADIANT PROTECTION SPF FLUID
zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15751-3506 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 150 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055) C13-16 ISOPARAFFIN (UNII: LED42LZG6O) CARNAUBA WAX (UNII: R12CBM0EIZ) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) FRAGRANCE 13576 (UNII: 5EM498GW35) TRIHEPTANOIN (UNII: 2P6O7CFW5K) LAUROYL LYSINE (UNII: 113171Q70B) NIACINAMIDE (UNII: 25X51I8RD4) MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M) ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P) MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP) DAUCUS CAROTA SUBSP. SATIVUS WHOLE (UNII: F9I9HZH3O3) COCONUT WATER (UNII: 267F5Y81NT) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) BAKUCHIOL (UNII: OT12HJU3AR) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PENTAERYTHRITYL STEARATE (UNII: T9BY3B181Z) METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P) ACAI (UNII: 46AM2VJ0AW) LEMON (UNII: 24RS0A988O) STARCH, TAPIOCA (UNII: 24SC3U704I) THIOCTIC ACID (UNII: 73Y7P0K73Y) PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576) RICE BRAN (UNII: R60QEP13IC) HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) UBIDECARENONE (UNII: EJ27X76M46) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15751-3506-1 1 in 1 BOX 09/01/2023 1 50 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 not final part352 09/01/2023 Labeler - Eminence Organic Skin Care (205753317)