AWAKEN BY QUALITY CHOICE LONG-LASTING OIL-FREE MOISTURIZER BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene and oxybenzone cream

Awaken by Quality Choice Long-Lasting Oil-Free Moisturizer Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Awaken by Quality Choice Long-Lasting Oil-Free Moisturizer Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 2.0%

Octisalate, 5.0%

Octocrylene, 4.0%

Oxybenzone, 3.0%

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.
• Reapply at least every 2 hours.
• Use water resistant sunscreen if swimming or sweating.
• 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, carbomer, cetearyl alcohol, ceteareth-20, glycerin, C12-15 alkyl benzoate, glyceryl stearate, PEG-100 stearate, diiosopropyl adipate, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, dimethicone, triethanolamine.

Package/Label Principal Display Panel

Awaken
by Quality Choice®

long lasting
facial moisturizer

BROAD SPECTRUM
SPF 15 SUNSCREEN

Oil free

Hypoallergenic

Non-comedogenic

Dermatologist tested

*Compare to Neutrogena®
Oil-Free Moisture Sensitive Skin Ingredients

4 FL OZ (118 mL)

Long-Lasting Facial Moisturizer Broad Spectrum SPF 15 Sunscreen penetrates deep into skin to provide instant moisturization and sun protection. Your skin will be left feeling softer, smoother, and look revitalized.

THE RESULTS

This light, non-greasy lotion efficiently moisturizes skin for up to 12 hours. The pure formula is quickly absorbed, leaving skin softer and smoother.

Broad spectrum SPF 15 sunscreen assists in fighting premature aging caused by daily exposure to the sun.

The oil-free formulation is quickly absorbed so it won’t clog pores leading to skin breakouts.
Long-Lasting Moisturizer Broad Spectrum SPF15 Sunscreen is:

• Hypoallergenic
• Fragrance-Free
• Alcohol-Free (no drying alcohol)

DIRECTIONS FOR USE

Use morning and evening, alone or under make-up.
Apply over entire face and neck.

Dermatologist Note:
Humectants increase the water content in skin without causing shine, clogging pores or smearing make-up. Many oil-free products contain moisturizing ingredients with these humectants properties, making them ideal for oily skin.

*This product is not manufactured or distributed by Neutrogena®, owner of the registered trademark Neutrogena® Oil-Free Moisture

SATISFACTION GUARANTEED

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

Manufactured in Israel
82026 CD C1

Carton Label

INGREDIENTS AND APPEARANCE

AWAKEN BY QUALITY CHOICE LONG-LASTING OIL-FREE MOISTURIZER BROAD SPECTRUM SPF 15 
avobenzone, octisalate, octocrylene and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-255-04	1 in 1 CARTON
1		118 g 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	09/01/2014

Labeler - Chain Drug Marketing Association (011920774)