Awaken By Quality Choice®

Awaken By Quality Choice®
SPL v1
SPL
SPL Set ID c3fd61cc-5645-4831-9917-55c24b161d70
Route
TOPICAL
Published
Effective Date 2014-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Octisalate (5 g) Octocrylene (4 g) Oxybenzone (3 g)
Inactive Ingredients
Water Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Glycerin Alkyl (c12-15) Benzoate Glyceryl Monostearate Peg-100 Stearate Diisopropyl Adipate Propylene Glycol Diazolidinyl Urea Methylparaben Propylparaben Dimethicone Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-09-01

Description

Avobenzone 2.0% Octisalate, 5.0% Octocrylene, 4.0% Oxybenzone, 3.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.0% Octisalate, 5.0% Octocrylene, 4.0% Oxybenzone, 3.0%

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.

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.
Do Not Use On
  • damaged or broken skin.
Active Ingredient

Avobenzone 2.0%

Octisalate, 5.0%

Octocrylene, 4.0%

Oxybenzone, 3.0%

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.

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.

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

Structured Label Content

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.
Purpose

Sunscreen

Warnings

For external use only.

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.
Do Not Use On (Do not use on)
  • damaged or broken skin.
Active Ingredient (Active ingredient)

Avobenzone 2.0%

Octisalate, 5.0%

Octocrylene, 4.0%

Oxybenzone, 3.0%

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.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor (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.

Package/label Principal Display Panel (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

Advanced Ingredient Data


Raw Label Data

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