Label: ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
- NDC Code(s): 57627-204-01
- Packager: Merle Norman Cosmetics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 17, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- INDICATIONS & USAGE
-
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.
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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
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone creamProduct 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) 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) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) .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) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ACETYL L-TYROSINE (UNII: DA8G610ZO5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 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) ADENOSINE (UNII: K72T3FS567) 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 final part352 11/29/2021 Labeler - Merle Norman Cosmetics, Inc. (008479388)
