DAILY FACIAL MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN- avobenzone, octocrylene cream 
Emilia Personal Care Inc.

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.

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America's Choice® daily facial moisturizer

Active ingredients

Avobenzone 3.0%

Octocrylene 10.0%

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 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 of age: 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 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

Other Information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, diisopropyl adipate, cyclopentasiloxane, glycerin, glyceryl stearate, PEG-100 stearate, titanium dioxide, alumina, simethicone, cetyl alcohol, polymethyl methacrylate, phenoxyethanol, triethanolamine, benzyl alcohol, xanthan gum, acrylates/C10-30 alkyl acrylate crosspolymer, tocopheryl acetate (vitamin E), carbomer, potassium cetyl phosphate, disodium EDTA.

Package/Label Principal Display Panel

America's Choice® daily facial moisturizer

non-greasy and lightweight

non-comedogenic

(won't clog pores)

fragrance-free & paba-free

dermatologist tested

*Compare to Cetaphil® Daily Facial Moisturizer SPF 15 ingredients

BROAD SPECTRUM SPF15 SUNSCREEN

UVA/UVB PROTECTION

4 FL OZ (118 mL)

*This product is not manufactured or distributed by Galderma®, owner of the registered trademark Cetaphil®

DISTRIBUTED BY ONPOINT, INC.
2 PARAGON DRIVE
MONTVALE, NJ 07645

Manufactured in Israel 2T326 AD C1

A+P 2T236 Image

Carton Label

DAILY FACIAL MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN 
avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW) (UNII: 99Q3C7L77T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42421-326-111 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/10/2014
Labeler - Emilia Personal Care Inc. (965445112)

Revised: 1/2014
Document Id: 71f476f9-c532-43a3-847b-a4bd3de519c8
Set id: 71f476f9-c532-43a3-847b-a4bd3de519c8
Version: 1
Effective Time: 20140109
 
Emilia Personal Care Inc.