Daily Facial Moisturizer Broad Spectrum SPF15 Sunscreen: Package Insert and Label Information

DAILY FACIAL MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN- avobenzone and 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.

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
(click image for full-size original)

Carton Label

DAILY FACIAL MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN
avobenzone, octocrylene cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42421-326
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIISOPROPYL ADIPATE
CYCLOMETHICONE 5
GLYCERIN
GLYCERYL 1-STEARATE
PEG-100 STEARATE
TITANIUM DIOXIDE
ALUMINUM OXIDE
SILICON DIOXIDE
CETYL ALCOHOL
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)
PHENOXYETHANOL
TROLAMINE
BENZYL ALCOHOL
XANTHAN GUM
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
.ALPHA.-TOCOPHEROL ACETATE
POTASSIUM CETYL PHOSPHATE
EDETATE DISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42421-326-11 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (42421-326-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/10/2014
Labeler — Emilia Personal Care Inc. (965445112)

Revised: 01/2014 Emilia Personal Care Inc.

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