ANTI-AGING EMULSION SPF 30- avobenzone, octinoxate, octisalate, oxybenzone cream

Anti-Aging Emulsion by

Drug Labeling and Warnings

Anti-Aging Emulsion by is a Otc medication manufactured, distributed, or labeled by Temmentec AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                            Purpose

Avobenzone 2.7%                            Sunscreen

Octinoxate   7.5%                            Sunscreen

Octisalate  5.0%                              Sunscreen

Oxybenzone  4.0%                         Sunscreen

-helps prevent sunburn
-for skin that burns easily
-provides moderate protection against sunburn
-higher SPF gives more sunburn protection

keep out of reach of children

-For external use only

-When using this product keep out of eyes

-Rinse with water to remove

-Stop use and ask a doctor if rash or irritation develops and lasts

-Do not use on infants under 6 months.

-apply daily after cleansing and toning

-smooth over face and throat

-apply evenly before sun exposure

-reapply as needed or after towel drying, swimming or perspiring

Inactive Ingredients: Water (Aqua), Butylene Glycol, Isostearyl Neopentanoate, Glycerin, Coco-Glucoside, Cyclohexasiloxane, Ethoxydiglycol, PEG-100 Stearate, Isononyl Isononanoate, Glyceryl Stearate, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Olea Europaea (Olive) Oil Unsaponifiables, Ursolic Acid, IIomastat, Algin, Caprylyl/Capric Triglyceride, Coconut Alcohol, Caprylyl/Capryl Glucoside, Acacia Senegal Gum, Ascorbyl Tetraisopalmitate, Serine, Tocopherol, DNA, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Carnosine, Camellia Sinensis Leaf Extract, Glycine Soja (Soybean) Oil Unsaponifiables, PEG-8, Phospholipids, Plankton Extract, Cyclopentasiloxane, Isodecyl Salicylate, Isopropylbenzyl Salicylate, Pollen Extract, Hydrolyzed Malt Extract, Propylene Glycol, Oligopeptide-5, Angelica Kelskei Extract, Oligopeptide-4, Dimethicone, Lecithin, Silybum Marlanum (Lady's Thistle) Fruit Extract, Tocopheryl Linoleate/Oleate, Echium Plantagineum Seed Oil, Polymethyl Methacrylate, Lauroyl Lysine, Sodium Acrylate/Acryloyldimethyl Taurate Copolymer, Sucrose, Xanthan Gum, Disodium EDTA, Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyisobutene, Carbomer, PPG-2 Isoceteth-20 Acetate, Mica, Fragrance (Parfum), Benzyl Alcohol, Linalool, Hydroxycitronellal, Alpha-Isomethyl Ionone, Amyl Cinnamal, Hexyl Cinnamal, Evernia Furfuracea (Treemoss) Extract, Geraniol, Benzyl Benzoate, Butylphenyl Methylpropional, Citronellol, Eugenol, Benzyl Salicylate, Limonene, Phenoxyethanol, Potassium Sorbate, Chlorophenesin, Methylparaben, Benzoic Acid, Ethylparaben.

PRINCIPAL DISPLAY PANEL

Anti-Aging Emulsion SPF 30

50 ml / 1.7 FL OZ.

INGREDIENTS AND APPEARANCE

ANTI-AGING EMULSION  SPF 30
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68807-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	2.8 g  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
COCO GLUCOSIDE (UNII: ICS790225B)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0)
EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)
URSOLIC ACID (UNII: P3M2575F3F)
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
ACACIA (UNII: 5C5403N26O)
SERINE (UNII: 452VLY9402)
CARNOSINE (UNII: 8HO6PVN24W)
BANCHA TEA LEAF/TWIG (UNII: EWI42IEH1C)
SOYBEAN OIL (UNII: 241ATL177A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
MILK THISTLE (UNII: U946SH95EE)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
POLYISOBUTYLENE (35000 MW) (UNII: 98553S1MHQ)
CARBOMER 934 (UNII: Z135WT9208)
MICA (UNII: V8A1AW0880)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
GERANIOL (UNII: L837108USY)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
CITRONELLAL (UNII: QB99VZZ7GZ)
EUGENOL (UNII: 3T8H1794QW)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68807-304-02	1 in 1 BOX	05/13/2011
1	NDC: 68807-304-01	50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/13/2011

Labeler - Temmentec AG (480586411)

Registrant - Temmentec AG (480586411)

Establishment
Name	Address	ID/FEI	Business Operations
Temmentec AG		480586411	manufacture(68807-304)