AWAKEN BY QUALITY CHOICE ILLUMINATING DAILY MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octisalate and octocrylene cream

Awaken by Quality Choice Illuminating Daily Moisturizer Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Awaken by Quality Choice Illuminating Daily Moisturizer Broad Spectrum SPF 15 Sunscreen 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 3.0%

Octisalate 5.0%

Octocrylene 8.0%

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, C12-15 alkyl benzoate, arachidyl alcohol, beheynl alcohol, arachidyl glucoside, cetearyl alcohol, cetearyl glucoside, steareth-2, glycerin, steareth-21, dimethicone, phenyl trimethicone, polyacrylamide, C13-14 isoparaffin, laureth-7, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, panthenol (pro-vitamin B5), polymethyl methacrylate, lecithin, soy isoflavones, polysorbate 80, alcohol, benzyl alcohol, disodium EDTA, fragrance, benzalkonium chloride, BHT, triethanolamine.

Package/Label Principal Display Panel

Awaken
by Quality Choice®

illuminating
daily moisturizer

BROAD SPECTRUM
SPF 15 SUNSCREEN

Clinically proven

Evens out skin tone & texture

Exclusive soy complex
& light diffusers

*Compare to Aveeno® Positively Radiant™

4 FL OZ. (120 mL)

THE RESULTS

Illuminating Daily Moisturizer Broad Spectrum SPF 15 Sunscreen is clinically proven to:

• Leave smoother skin
• Improve skin’s tone and texture
• Visibly even out discolorations
• Improve skin’s radiance

This unique moisturizer has an exclusive soy complex and light diffusers that work together to naturally even out skin tone and texture, immediately reflecting light to visibly smooth skin imperfections, bringing out skin’s natural radiance. This light and quickly absorbed moisturizer is gentle enough for sensitive skin to help maintain healthy-looking skin.

DIRECTIONS FOR USE

After cleansing, smooth over face and neck every day for healthier, younger-looking skin.

Soy is nature’s secret for naturally radiant skin. Soy in known for multiple health & skin benefits including: moisturizing, texture smoothing, and evening out skin tone for healthier looking skin.

This oil-free hypoallergenic and non-comedogenic product is gentle enough for everyday use.

Dermatologists recommend the everyday use of an SPF 15 sunscreen as essential to healthy skin care.

*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Aveeno® Positively Radiant™

SATISFACTION GUARANTEED

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

Made in Israel
52326 CD C1

Carton Label

INGREDIENTS AND APPEARANCE

AWAKEN BY QUALITY CHOICE ILLUMINATING DAILY MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-254
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
STEARETH-2 (UNII: V56DFE46J5)
GLYCERIN (UNII: PDC6A3C0OX)
STEARETH-21 (UNII: 53J3F32P58)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOPROPYLPARABEN (UNII: A6EOX47QK0)
PANTHENOL (UNII: WV9CM0O67Z)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SOY ISOFLAVONES (UNII: 71B37NR06D)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-254-04	1 in 1 CARTON
1		120 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)