Label: PREVENTAGE FIRMING DEFENSE NORMAL/OILY BROAD SPECTRUM SPF 15 MERLE NORMAN- avobenzone, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57627-119-01 - 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 January 27, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions For sunscreen use:
Apply liberally 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 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.
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INACTIVE INGREDIENT
Inactive ingredients: Water(Aqua), Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hamamelis Virginiana (Witch Hazel) Water, Glyceryl Polymethacrylate, Propylene Glycol, Biosaccharide Gum-1, Sorbitan Stearate, Palmitoyl Oligopeptide, Dipalmitoyl Hydroxyproline, Hydrolyzed Elastin, Collagen Amino Acids, Hydrolyzed Rice Protein, Hydrolyzed Malt Extract, Ilex Aquifolium (Holly) Leaf Extract, Calluna Vulgaris Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Ruscus Aculeatus Root Extract, Ginkgo Biloba Leaf Extract, Camellia Sinensis Leaf Extract, Euphrasia Officinalis Extract, Echinacea Angustifolia Extract, Bisabolol, Glycyrrhetinic Acid, Hyaluronic Acid, Tocopheryl Acetate, Ascorbyl Palmitate, Retinyl Palmitate, Lecithin, Dimethicone, Phenyl Trimethicone, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, PPG-20 Methyl Glucose Ether, Octyldodecyl Neopentanoate, Glycerin, Myristyl Lactate, Sorbitol, Phospholipids, Stearic Acid, Stearyl Alcohol, PEG-100 Stearate, Polysorbate 60, Triethanolamine, Alcohol, Caprylyl Glycol, Polyquaternium-24, Sodium Oleanolate, Sodium Ursolate, PEG-7M, PEG-8, Carbomer, Silica, PVP, Phenoxyethanol, Chlorphenesin, Methylisothiazolinone, Disodium EDTA, Trisodium EDTA
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREVENTAGE FIRMING DEFENSE NORMAL/OILY BROAD SPECTRUM SPF 15 MERLE NORMAN
avobenzone, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.064 g in 56 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.264 g in 56 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT) ILEX AQUIFOLIUM LEAF (UNII: 9Z32IEA9F7) CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV) CUCUMBER (UNII: YY7C30VXJT) RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q) GINKGO (UNII: 19FUJ2C58T) GREEN TEA LEAF (UNII: W2ZU1RY8B0) EUPHRASIA STRICTA (UNII: C9642I91WL) ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) LEVOMENOL (UNII: 24WE03BX2T) ENOXOLONE (UNII: P540XA09DR) HYALURONIC ACID (UNII: S270N0TRQY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV) PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) GLYCERIN (UNII: PDC6A3C0OX) MYRISTYL LACTATE (UNII: 1D822OC34X) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PEG-100 STEARATE (UNII: YD01N1999R) POLYSORBATE 60 (UNII: CAL22UVI4M) TROLAMINE (UNII: 9O3K93S3TK) ALCOHOL (UNII: 3K9958V90M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM OLEANOLATE (UNII: LVB19G8AUT) SODIUM URSOLATE (UNII: NV5D25VL1O) POLYETHYLENE GLYCOL 300000 (UNII: 4QIB4U4CQR) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) EDETATE DISODIUM (UNII: 7FLD91C86K) EDETATE TRISODIUM (UNII: 420IP921MB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-119-01 56 g in 1 JAR; Type 0: Not a Combination Product 08/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/15/2012 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(57627-119)
