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NDC 69842-0080-01 Beauty 360 Accelerated Wrinkle Repair Moisturizer 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL Details

Beauty 360 Accelerated Wrinkle Repair Moisturizer 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL

Beauty 360 Accelerated Wrinkle Repair Moisturizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Health. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	69842-0080
Product ID	69842-080_16872f78-fbf7-4de9-b9f3-6f5361bd3dfd
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Beauty 360 Accelerated Wrinkle Repair Moisturizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	homosalate, octisalate, avobenzone, octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	20; 40; 40; 20
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	CVS Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0080-01 (69842008001)

Pricing Information	N/A
NDC Package Code	69842-080-01
Billing NDC	69842008001
Package	1 BOTTLE in 1 CARTON (69842-080-01) / 30 mL in 1 BOTTLE
Marketing Start Date	2017-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 59b05c6d-2e35-4943-8269-c31c74dfd479 Details

Active ingredients

Avobenzone 2.0%

Homosalate 4.0%

Octisalate 4.0%

Octocrylene 2.0%

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 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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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

M050891

FP121

Principal Display Panel - Carton Label

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 OZ

(29 mL)

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 OZ (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:69842-080
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S)	homosalate	40 mg in 1 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	40 mg in 1 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX)	avobenzone	20 mg in 1 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM)	octocrylene	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-080-01	1 in 1 CARTON	04/01/2017
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2017

Labeler - CVS Health (062312574)

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

Name	Address	ID/FEI	Business Operations
Establishment
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	MANUFACTURE(69842-080) , PACK(69842-080) , LABEL(69842-080) , ANALYSIS(69842-080)

Revised: 3/2017

Document Id: 16872f78-fbf7-4de9-b9f3-6f5361bd3dfd

Set id: 59b05c6d-2e35-4943-8269-c31c74dfd479

Version: 1

Effective Time: 20170314