NEOSTRATA SKIN ACTIVE MATRIX SUPPORT SPF 30- avobenzone, octinoxate, and octisalate cream

NeoStrata Skin Active Matrix Support by

Drug Labeling and Warnings

NeoStrata Skin Active Matrix Support by is a Otc medication manufactured, distributed, or labeled by NeoStrata Company Inc., Cosmetic Essence, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3%,
Octinoxate 7.5%,
Octisalate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Broad Spectrum SPF 30
• 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 product is 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 sunscreen 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 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-sleeve 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/Eau, Acetyl Glucosamine, Butyloctyl Salicylate, Cyclopentasiloxane, Glyceryl Stearate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, PEG-100 Stearate, Dimethicone, Cetyl Alcohol, Nylon-12, Triacontanyl PVP, Retinol, Citric Acid, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Coffea Arabica (Coffee) Fruit Extract, DL-Alpha Tocopheryl Acetate, Rosa Damascena Flower Oil, Punica Granatum Extract, Arginine, Glycerin, Propylene Glycol, Cyclohexasiloxane, Caprylyl Glycol, Dimethiconol, Disodium EDTA, BHT, Xanthan Gum, PEG-75 Stearate, Ceteth-20, Steareth-20, Polysorbate 20, Triethyl Citrate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Methyldihydrojasmonate, Carbomer, Ethylene Brassylate, Phenoxyethanol, Chlorphenesin, Yellow 5 (CI 19140), Red 33 (CI 17200).

Questions?

1-800-628-9904

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

NEOSTRATA®
SKIN ACTIVE

REPAIR

Matrix Support
with Sunscreen Broad
Spectrum SPF 30

Cream

DIN 02470527

NET WT
50 g/1.7 OZ

INGREDIENTS AND APPEARANCE

NEOSTRATA SKIN ACTIVE MATRIX SUPPORT   SPF 30
avobenzone, octinoxate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-3042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58414-3042-1	1 in 1 CARTON	07/18/2013
1		50 g in 1 TUBE; 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	07/18/2013

Labeler - NeoStrata Company Inc. (605754829)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC.		032565959	MANUFACTURE(58414-3042)