BEAUTY 360 ACCELERATED WRINKLE REPAIR MOISTURIZER- homosalate, octisalate, avobenzone, octocrylene liquid

Beauty 360 Accelerated Wrinkle Repair Moisturizer by

Drug Labeling and Warnings

Beauty 360 Accelerated Wrinkle Repair Moisturizer by is a Otc medication manufactured, distributed, or labeled by AMCOL Health & Beauty Solutions, Inc. DBA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

HBS Code (Labeler): FP12101-30.1

Distributor: CVS Pharmacy, Inc.

Human OTC Drug

Active Ingredients: Avobenzone 2.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 2.0%

CARTON TEXT

________________________________________________________

beauty 360™

ACCELERATED WRINKLE REPAIR MOISTURIZER

MEASURABLE RESULTS

Rapid retinol SR

Formulated without parabens

UVA/UVB protection

BROAD SPECTRUM SPF 30 SUNSCREEN

SPF 30

COMPARE TO NEUTROGENA® RAPID WRINKLE REPAIR MOISTURIZER*

CVS pharmacy®

1 FL (29 mL)

beauty 360™

Drug Facts

Active ingredients

Avobenzone 2.0%

Homosalate 4.0%

Octisalate 4.0%

Octocrylene 2.0%

Purpose

Sunscreen

Sunscreen

Sunscreen

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 cause 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: 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 sunlight

Inactive ingredients

Water, Styrene/Acrylates Copolymer, Glycerin, Dimethicone, Isononyl Isononanoate, Trisiloxane, Steareth-21, Pentylene Glycol, Cetyl Alcohol, Phenoxyethanol, Silica, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Steareth-2, PEG-100 Stearate, Glyceryl Stearate, Polysorbate 20, Dimethicone/Vinyl Dimethicone Crosspolymer, Chlorphenesin, Retinol, Xanthan Gum, BHT, Ethylhexylglycerin, Disodium EDTA, Nylon-12, Sodium Hydroxide, Hydrolyzed Myrtus Communis Leaf Extract, Stearyl Alcohol, Tocopheryl Acetate, Sodium Hyaluronate, Propyl Gallate, Ascorbic Acid, Fragrance

beauty 360™

Beauty 360 offers a collection of superior quality products to suit your individual daily needs from head to toe.

Beauty 360: reinventing beauty.

Accelerated Wrinkle Repair Moisturizer with Broad Spectrum SPF 30 Sunscreen works quickly for measurable results.

Retinol is clinically proven to help:

Reduce the appearance of age spots and discolorations

Even out skin tone

Minimize the visible signs of aging, including fine lines and wrinkles

*This product is not manufactured or distributed by Johnson & Johnson Consumer Companies Inc., owner of the registered trademark Neutrogena®.

This product is covered by U.S. Patents 6,500,411 and 6,716,418

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2016 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A. of U.S. and foreign components

V-13649

CVS® Quality

Money Back Guarantee

What is retinol?

Retinol is a form of Vitamin A that naturally absorbs into your skin. It helps your skin achieve a smoother, more youthful appearance.

Rapid retinol SR

Combines a potent level of pure retinol with plant-based Phyto-Complex to help skin look and feel younger.

It is a unique combination of the following ingredients:

Retinol SR

Sustained Release technology contains wrinkle-smoothing retinol and helps reduce the appearance of age spots

Hyaluronic Acid

Hydrates skin to provide line-plumping moisture for a more rejuvenated appearance

Phyto-Complex

Helps improve skin tone and reduces the appearance of wrinkles

Warnings:

You may experience mild tingling and/or redness. This is a sign that the product is working. If discomfort occurs, reduce use to every other day. Discontinue use if irritation persists. Protect this product from excessive heat and direct sun.

Caution: For external use only. Avoid getting into eyes. If product gets into eyes, rinse thoroughly with water. Keep out of reach of children.

M050891

FP121

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end of text

160225

AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care

301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com

lauren.haase@amcol.com

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Carton Label

beauty 360™

ACCELERATED WRINKLE REPAIR
MOISTURIZER

MEASURABLE RESULTS

Rapid retinol SR

Formulated without parabens

UVA/UVB protection

BROAD SPECTRUM SPF 30 SUNSCREEN

SPF 30

COMPARE TO NEUTROGENA® RAPID WRINKLE REPAIR MOISTURIZER*

CVS pharmacy®

1 FL (29 mL)

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Bottle Label

beauty 360™

ACCELERATED WRINKLE REPAIR

MOISTURIZER

MEASURABLE RESULTS

Rapid retinol SR

Formulated without parabens

BROAD SPECTRUM SPF 30 SUNSCREEN

SPF 30

1 FL (29 mL)

INGREDIENTS AND APPEARANCE

BEAUTY 360 ACCELERATED WRINKLE REPAIR MOISTURIZER 
homosalate, octisalate, avobenzone, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68634-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S)	homosalate	40 g  in 2 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	40 g  in 2 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX)	avobenzone	20 g  in 2 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM)	octocrylene	20 g  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
styrene/acrylamide copolymer (mw 500000) (UNII: 5Z4DPO246A)
glycerin (UNII: PDC6A3C0OX)
dimethicone (UNII: 92RU3N3Y1O)
isononyl Isononanoate (UNII: S4V5BS6GCX)
trisiloxane (UNII: 9G1ZW13R0G)
steareth-21 (UNII: 53J3F32P58)
pentylene glycol (UNII: 50C1307PZG)
cetyl alcohol (UNII: 936JST6JCN)
phenoxyethanol (UNII: HIE492ZZ3T)
silicon dioxide (UNII: ETJ7Z6XBU4)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)
carbomer copolymer type b (allyl pentaerythritol crosslinked) (UNII: 809Y72KV36)
steareth-2 (UNII: V56DFE46J5)
peg-100 stearate (UNII: YD01N1999R)
glyceryl monostearate (UNII: 230OU9XXE4)
polysorbate 20 (UNII: 7T1F30V5YH)
dimethicone/vinyl dimethicone crosspolymer (soft particle) (UNII: 9E4CO0W6C5)
chlorphenesin (UNII: I670DAL4SZ)
retinol (UNII: G2SH0XKK91)
xanthan gum (UNII: TTV12P4NEE)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
ethylhexylglycerin (UNII: 147D247K3P)
edetate disodium (UNII: 7FLD91C86K)
nylon-12 (UNII: 446U8J075B)
sodium hydroxide (UNII: 55X04QC32I)
myrtus communis leaf (UNII: U20N87188F)
stearyl alcohol (UNII: 2KR89I4H1Y)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
hyaluronate sodium (UNII: YSE9PPT4TH)
propyl Gallate (UNII: 8D4SNN7V92)
ascorbic acid (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68634-054-01	1 in 1 CARTON	04/01/2016
1		30 mL 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	04/01/2016

Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	MANUFACTURE(68634-054) , PACK(68634-054) , LABEL(68634-054) , ANALYSIS(68634-054)