SIMPLE VITAL VITAMIN DAY SPF 15- homosalate, octisalate, avobenzone, and octocrylene emulsion

Simple by

Drug Labeling and Warnings

Simple by is a Otc medication manufactured, distributed, or labeled by Cosmetic Laboratories of America. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients:	Purpose:
Homosalate 12.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Avobenzone 3.0%	Sunscreen
Octocrylene 2.7%	Sunscreen

USE

helps prevent sunburn.

Warnings

• - For external use only.

• - Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

• - When using this product keep out of eyes.
  Rinse with water to remove.

• - Stop use and ask a doctor if a rash and irritation develops and lasts.

Other Information

Intended for moderate daily sun protection from incidental sun exposure. For prolonged sun exposure, use additional sunscreen.

Directions

After cleansing, apply evenly to face and neck with fingertips prior to sun exposure. For children under 6 months of age, ask doctor.

Inactive Ingredients

Water (Aqua, Eau), Glycerin, C12-15 Alkyl Benzoate, Silica, Pentylene Glycol, Tocopheryl Acetate, Panthenol, Cetearyl Alcohol, Steareth-21, Steareth-2, Arachidyl Alcohol, Polyacrylamide, Caprylyl Glycol, Behenyl Alcohol, C13-14 Isoparaffin, Disodium EDTA, Xanthan Gum, Cetearyl Glucoside, Arachidyl Glucoside, Allantoin, Bisabolol, Laureth-7, Triethanolamine, Methylisothiazolinone, Phenoxyethanol.

Questions?

1-866-752-4602

SPL UNCLASSIFIED SECTION

Distributed by: Alberto Culver USA, Inc.
Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 50g Jar Carton

NEW!

simple ®

SENSITIVE SKIN EXPERTS

vital vitamin
D A Y   C R E A M
SPF 15 | UVA/UVB SUNSCREENS

KIND TO SKIN

2
VITAL
VITAMINS

3
SKIN LOVING
NUTRIENTS

0
NO PERFUME
NO DYES

Vitamin goodness
for naturally healthy
looking skin

net wt
1.7 oz | 50g

INGREDIENTS AND APPEARANCE

SIMPLE   VITAL VITAMIN DAY SPF 15
homosalate, octisalate, avobenzone, and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54726-2000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.12 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.027 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Pentylene Glycol (UNII: 50C1307PZG)
Panthenol (UNII: WV9CM0O67Z)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Steareth-21 (UNII: 53J3F32P58)
Steareth-2 (UNII: V56DFE46J5)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Caprylyl Glycol (UNII: 00YIU5438U)
Docosanol (UNII: 9G1OE216XY)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Edetate Disodium (UNII: 7FLD91C86K)
Xanthan Gum (UNII: TTV12P4NEE)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Allantoin (UNII: 344S277G0Z)
Levomenol (UNII: 24WE03BX2T)
Laureth-7 (UNII: Z95S6G8201)
Trolamine (UNII: 9O3K93S3TK)
Methylisothiazolinone (UNII: 229D0E1QFA)
Phenoxyethanol (UNII: HIE492ZZ3T)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54726-2000-1	1 in 1 CARTON
1		50 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2012

Labeler - Cosmetic Laboratories of America (617165329)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Laboratories of America		617165329	ANALYSIS, MANUFACTURE