ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

ANTI-AGING COMPLEX BROAD SPECTRUM 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

PURPOSE

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 by the sun

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

Warnings

For external use only

Do not use on damaged or broken skin

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

INDICATIONS & USAGE

Stop use and ask a doctor if rush occurs.

DOSAGE & ADMINISTRATION

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
• 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
• children under 6 months: Ask a doctor
• Apply to cleansed and toned skin prior to sun exposure.

INACTIVE INGREDIENT

Inactive ingredients: Aqua/Water/Eau, Glycerin, Ethoxydiglycol, Butylene Glycol, Alcohol Denat., Cyclopentasiloxane, Glycereth-26, Isostearyl Neopentanoate, Nylon-12, Glyceryl Stearate, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Isononyl Isononanoate, Phenoxyethanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polymethyl Methacrylate, Hydrolyzed Malt Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Hydrogenated Lecithin, PEG-100 Stearate, Caprylyl Glycol, Mica (CI 77019), Coco-Glucoside, Ethylhexylglycerin, Tetrasodium EDTA, Xanthan Gum, Coconut Alcohol, BHT, Bisabolol, Hexylene Glycol, Propylene Glycol, Caprylyl/Capryl Glucoside, Opuntia Ficus-Indica Stem Extract, Hydroxypropyl Cyclodextrin, Acetyl Tyrosine, Phospholipids, Panax Ginseng Root Extract, Camellia Sinensis Leaf Extract, Proline, Silica, Adenosine Triphosphate, Hydrolyzed Vegetable Protein, Acetyl Octapeptide-3, Equisetum Arvense Extract, Acetylarginyltryptophyl Diphenylglycine, Ascorbyl Palmitate, Retinyl Palmitate, Palmitoyl Tripeptide-38, Tocopheryl Acetate.

OTHER SAFETY INFORMATION

Questions or comments?

1-800-421-2060 9:00 a.m. - 5:00 p.m. PST

STORAGE AND HANDLING

Other information

• protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

ANTI-AGING COMPLEX EMULSION

BROAD SPECTRUM SPF 30

MERLE NORMAN

31 g NET WT. 1.1 OZ.

INGREDIENTS AND APPEARANCE

ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.35 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
MICA (UNII: V8A1AW0880)
EDETATE SODIUM (UNII: MP1J8420LU)
XANTHAN GUM (UNII: TTV12P4NEE)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ASIAN GINSENG (UNII: CUQ3A77YXI)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERETH-26 (UNII: NNE56F2N14)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
NYLON-12 (UNII: 446U8J075B)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)
PROLINE (UNII: 9DLQ4CIU6V)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ALCOHOL (UNII: 3K9958V90M)
PEG-100 STEARATE (UNII: YD01N1999R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
ACETYLARGINYLTRYPTOPHYL DIPHENYLGLYCINE (UNII: 9O32SH1GPH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ACETYL L-TYROSINE (UNII: DA8G610ZO5)
ADENOSINE (UNII: K72T3FS567)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LEVOMENOL (UNII: 24WE03BX2T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
TRIPOLYPHOSPHATE ION (UNII: 5798IYA5AY)
COCO GLUCOSIDE (UNII: ICS790225B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-204-01	31 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/29/2021

Labeler - Merle Norman Cosmetics, Inc. (008479388)