Exuviance Age Reverse Day Repair Spf 30 (Avobenzone, Octinoxate, And Octisalate) Cream [Neostrata Company Inc.] -

EXUVIANCE AGE REVERSE DAY REPAIR SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) CREAM [NEOSTRATA COMPANY INC.]
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NDC	58414-2040-1
Set ID	60998d76-dbb7-4571-bb0c-b60d83d9f07c
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

Butyl Methoxydibenzoylmethane (Avobenzone) 3.0%
Ethylhexyl Methoxycinnamate (Octinoxate) 7.5%
Ethylhexyl Salicylate (Octisalate) 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

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

A light peeling or tingling sensation may occur when using this high strength formulation. If uncomfortable, reduce usage to every other day until skin adjusts.
Directions
- Apply liberally to face and neck daily following cleansing, 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- 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 10am - 2pm
  - Wear long-sleeved shirts, pants, hats and sunglasses
- Children under 6 months: Ask a doctor
Other information
- Store at 15°C-30°C (59°F-86°F)
- Protect this product from excessive heat and direct sun
Inactive ingredients

Aqua (Water), Acetyl Glucosamine, Butyloctyl Salicylate, Cyclopentasiloxane, Glyceryl Stearate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, PEG-100 Stearate, Dimethicone, Cetyl Alcohol, Nylon-12, Triacontanyl PVP, Retinol, Tocopheryl (Vitamin E) Acetate, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Punica Granatum (Pomegranate) Extract, Coffea Arabica (Coffee) Fruit Extract, Rosa Damascena Flower Oil, Arginine, Glycerin, Propylene Glycol, Triethyl Citrate, Cyclohexasiloxane, Caprylyl Glycol, Citric Acid, Disodium EDTA, BHT, PEG-75 Stearate, Ceteth-20, Steareth-20, Dimethiconol, Polysorbate 20, Xanthan Gum, Ammonium Acryloyldimethyltaurate/VP Copolymer, Methyldihydrojasmonate, Ethylene Brassylate, Chlorphenesin, Phenoxyethanol, CI 19140 (Yellow 5), CI 17200 (Red 33)
Questions or comments?

Call toll free 1-800-225-9411 (9am – 5pm ET)
PRINCIPAL DISPLAY PANEL - 50 g Tube Carton
DERMATOLOGIST DEVELOPED

Exuviance®
AGE REVERSE

Day Repair

Sunscreen
Broad Spectrum SPF 30

Triple Firming Complex
NeoGlucosamine®, Retinol & Peptides
Multi-Antioxidant Formula
- Firms and plumps deeper wrinkles
- Targets uneven pigmentation
- Protects and repairs
Net Wt 50 g / 1.75 oz

INGREDIENTS AND APPEARANCE

EXUVIANCE AGE REVERSE DAY REPAIR SPF 30
avobenzone, octinoxate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58414-2040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
NYLON-12 (UNII: 446U8J075B)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
RETINOL (UNII: G2SH0XKK91)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q)
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
ARGININE (UNII: 94ZLA3W45F)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG-75 STEARATE (UNII: OT38R0N74H)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
XANTHAN GUM (UNII: TTV12P4NEE)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58414-2040-1	1 in 1 CARTON	07/12/2013	10/02/2021
1		50 g in 1 TUBE; 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	07/12/2013	10/02/2021

Labeler - NeoStrata Company Inc. (605754829)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmetic Essence, LLC.		825646862	MANUFACTURE(58414-2040)

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Medic

EXUVIANCE AGE REVERSE DAY REPAIR SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) CREAM [NEOSTRATA COMPANY INC.]

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