AWAKEN BY QUALITY CHOICE ANTI-WRINKLE AND FIRMING MOISTURIZER DAY BROAD SPECTRUM SPF18 SUNSCREEN- avobenzone, octisalate and octocrylene cream

Awaken by Quality Choice Anti-Wrinkle and Firming Moisturizer Day Broad Spectrum SPF18 Sunscreen by

Drug Labeling and Warnings

Awaken by Quality Choice Anti-Wrinkle and Firming Moisturizer Day Broad Spectrum SPF18 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, 2.0%

Octisalate, 5.0%

Octocrylene, 5.0%

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, cyclohexasiloxane, glycerin, titanium dioxide, glyceryl stearate, PEG-100 stearate, beeswax, myristyl myristate, stearic acid, palmitic acid, polyglyceryl-10 pentastearate, behenyl alcohol, sodium steroyl lactylate, tocopheryl acetate (vitamin E), butylene glycol, carbomer, polysorbate 20, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, cetyl alcohol, stearyl alcohol, hydrolyzed soy protein, dipalmitoyl hydroxyproline, fragrance, triethanolamine, glycine soja (soybean) protein, xanthan gum, retinyl palmitate (vitamin A), phenoxyethanol, PEG-20 stearate, potassium sorbate, sodium benzoate, phenethyl alcohol, alcohol denat., chlorphenesin.

Package/Label Principal Display Panel

Awaken
by Quality Choice®

anti-wrinkle
& firming
moisturizer

BROAD SPECTRUM
SPF 18 SUNSCREEN

Day cream with sunscreen

With encapsulated pro-vitamin A
& Matrixyl™ & Sepilift™

*Compare to L’Oreal® Advanced Revitalift® Complete Day Cream SPF18 ingredients

NET WT 1.7 FL OZ (48 g)

Advanced Anti-Wrinkle Action: Encapsulated Pro-Vitamin A and Sepilift™ will hasten skin renewal, reducing the amount of fine lines and wrinkles and their depth. Results can be seen in just two weeks. The new technology will continually act to help fight the signs of aging.

Innovative Firming: Matrixyl™ has proven to show renewed elastin and collagen fibers. Skin’s surface is remodeled, becoming more resilient and toned.

Continuous Moisturization & Skin Protection: Provides 24 hour moisturization to soothe dry skin. Broad spectrum UVA/UVB SPF18 protects the skin and prevents skin damage by UV exposure.

THE RESULTS

Skin’s elasticity is improved. Visible reduction of wrinkles and skin looks smoother, firmer skin.

DIRECTIONS FOR USE

Every day, smooth gently onto face and neck until thoroughly absorbed. Use in the AM, alone or under makeup.

Matrixyl™ is a registered trademark owned by Sederma.

Sepilift™ is a registered trademark owned by Seppic.

Now experience the advanced actions against the signs of skin aging. New Anti-Wrinkle & Firming Moisturizer Broad Spectrum SPF18 Sunscreen, with effective encapsulated Pro-Vitamin A, Matrixyl™ and Sepilift™ will increase cell turnover, reduce wrinkles, firm the skin, and provide 24 hour moisturization.

FORMULA ESSENTIALS

• UV SPF18 sunscreen
• Non-Comedogenic
• Dermatologist tested for gentleness
• Non-greasy

*This product is not manufactured or distrubted by L’Oreal®, owner of the registered trademark Revitalift®.

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

SATISFACTION GUARANTEED

Manufactured in ISRAEL
37815 CD C1

Carton Label

INGREDIENTS AND APPEARANCE

AWAKEN BY QUALITY CHOICE ANTI-WRINKLE AND FIRMING MOISTURIZER DAY BROAD SPECTRUM SPF18 SUNSCREEN 
avobenzone, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-251
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	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
YELLOW WAX (UNII: 2ZA36H0S2V)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
DOCOSANOL (UNII: 9G1OE216XY)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SOY PROTEIN (UNII: R44IWB3RN5)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-20 STEARATE (UNII: NBX892EA57)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ALCOHOL (UNII: 3K9958V90M)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-251-02	1 in 1 CARTON
1		48 g in 1 JAR; 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)