EVENLY RADIANT BRIGHTENING DAY CREME SPF 15- octinoxate and zinc oxide cream

Evenly Radiant Brightening Day Creme SPF 15 by

Drug Labeling and Warnings

Evenly Radiant Brightening Day Creme SPF 15 by is a Otc medication manufactured, distributed, or labeled by derma e. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredients

Octinoxate 5.5%, Zinc Oxide 5.5%

Purpose

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 sun

Warnings

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 a doctor

• if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor
• 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 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

Inactive ingredients

Purified Water (Aqua), Cetearyl Olivate, Sorbitan Olivate, Propanediol, Glycerin, Carthamus Tinctorius (Safflower) Seed Oil, Niacinamide (Vitamin B3), Capric/Caprylic Triglyceride, Cetyl Alcohol, Glyceryl Stearate Citrate, Arctostaphylos Uva Ursi (Bearberry) Leaf Extract, Ascorbyl Palmitate (C-Ester), Lilium Candidum (Madonna Lily) Leaf Cell Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Tocopheryl Acetate (Vitamin E), Panthenol (Provitamin B5), Vitis Vinifera (Grape) Seed Oil, Epilobium Angustifolium (Canadian Willowherb™) Extract, Organic Camellia Sinensis (Green Tea) Leaf Extract1 (.1%), Organic Olea Europaea (Olive) Fruit Oil1 (.1%), Glyceryl Stearate, Polysorbate 20, Potassium Sorbate, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin.

1 Certified Organic by Quality Assurance International or USDA.

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-933-9344

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Distributed by derma e®
Simi Valley, CA 93063, USA

PRINCIPAL DISPLAY PANEL - 56 g Jar Box

all
dry
normal
oily

CRUELTY-FREE PARABEN-FREE
natural
100% VEGAN

derma e®

Evenly Radiant®
Brightening
Day Crème SPF 15
With Vitamin C

net wt 2 oz / 56 g e Broad Spectrum SPF 15 Sunscreen

INGREDIENTS AND APPEARANCE

EVENLY RADIANT BRIGHTENING DAY CREME SPF 15 
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-0333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	55 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	55 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Propanediol (UNII: 5965N8W85T)
Glycerin (UNII: PDC6A3C0OX)
Safflower Oil (UNII: 65UEH262IS)
Niacinamide (UNII: 25X51I8RD4)
Tricaprylin (UNII: 6P92858988)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Stearate Citrate (UNII: WH8T92A065)
Cetearyl Olivate (UNII: 58B69Q84JO)
Sorbitan Olivate (UNII: MDL271E3GR)
Arctostaphylos Uva-Ursi Leaf (UNII: 3M5V3D1X36)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Lilium Candidum Bulb (UNII: AHG15J8AM0)
Glycyrrhiza Glabra (UNII: 2788Z9758H)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Panthenol (UNII: WV9CM0O67Z)
Grape Seed Oil (UNII: 930MLC8XGG)
Epilobium Angustifolium Leaf (UNII: 7NV86426N2)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Olive Oil (UNII: 6UYK2W1W1E)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Polysorbate 20 (UNII: 7T1F30V5YH)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Xanthan Gum (UNII: TTV12P4NEE)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-0333-0	1 in 1 BOX
1		56 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/17/2014

Labeler - derma e (148940450)