ANTI-AGING COMPLEX SPF 30 MERLE NORMAN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone emulsion

Anti-Aging Complex SPF 30 by

Drug Labeling and Warnings

Anti-Aging Complex SPF 30 by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients purpose

Avobenzone 3.0% Sunscreen

Homosalate 8.0% Sunscreen

Octisalate 4.0 % Sunscreen

Octocrylene 2.35% Sunscreen

Oxybenzone 5.0% 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.

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

Stop use and ask a doctor if rash occurs.

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.

Directions

for Sunscreen use

-Apply Liberally and evenly 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 skn cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protection measures including:

-limit time in the sun, especially from 10 a.m. to 2 p.m.

- wear long-sleeved shirts, pants, hats and and sunglasses

Children under 6 months: Ask a doctor

Inactive ingredients: water(aqua), glycerin, ethoxydiglycol, butylene glycol, cyclopentasiloxane, glycereth-26, isostearyl neopentanoate, alcohol denat., nylon-12, acetyl octapeptide-3, palmitoyl tripeptide-38, acetylarginyltryptophyl diphenylglycine, acetyl tyrosine, proline, adenosine triphosphate, hydrolyzed malt extract, hydrolyzed vegetable protein, optunia ficus-indica stem extract, camellia sinensis leaf extract, equisetum arvense extract, panax ginseng root extract, bisabolol, tocopheryl acetate, ascorbyl palmitate, retinyl palmitate, isononyl isononanoate, caprylyl/capryl glucoside, coco-glucoside, hydrogenated lecithin, glyceryl stearate, peg-100 stearate, ammonium acryloyldimethyltaurate/VP copolymer, polymethyl methacrylate, sodium acrylate/sodium acryloyldimethyl taurate copolymer, xanthan gum, phospholipids, hydroxypropyl cyclodextrin, bis-ethylhexyl hydroxydimethoxy benzylmalonate, caprylyl glycol, propylene glycol, polyisobutene, coconut alcohol, silica, tetrasodium EDTA, BHT, phenoxyethanol, methylisothiazolinone, mica

PRINCIPAL DISPLAY PANEL

Anti-Aging Complex Emulsion

Broad Spectrum SPF 30

Merle Norman

Established in Los Angeles since 1931

31g Net Wt. 1.1 oz

INGREDIENTS AND APPEARANCE

ANTI-AGING COMPLEX SPF 30  MERLE NORMAN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.93 g  in 31 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.48 g  in 31 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.24 g  in 31 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.729 g  in 31 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.55 g  in 31 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERETH-26 (UNII: NNE56F2N14)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
NYLON-12 (UNII: 446U8J075B)
ACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)
N-ACETYLTYROSINE (UNII: DA8G610ZO5)
PROLINE (UNII: 9DLQ4CIU6V)
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)
BARLEY MALT SYRUP (UNII: 22P8DKP670)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)
ASIAN GINSENG (UNII: CUQ3A77YXI)
LEVOMENTHOL (UNII: BZ1R15MTK7)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
COCO GLUCOSIDE (UNII: ICS790225B)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
XANTHAN GUM (UNII: TTV12P4NEE)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-149-02	1 in 1 CARTON	11/08/2012
1	NDC: 57627-149-01	31 g 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	11/08/2012

Labeler - Merle Norman Cosmetics, Inc. (008479388)

Registrant - Merle Norman Cosmetics, Inc. (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics, Inc.		008479388	manufacture(57627-149)