Label: PREVENTAGE FIRMING DEFENSE CREME NORMAL/DRY MERLE NORMAN- avobenzone, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57627-121-01, 57627-121-02 - 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)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 1.9% Sunscreen
Octocrylene 9.4% SunscreenUses
-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 product is 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 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 sin 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.
Inactive Ingredients: Water (Aqua), Glycerin, Butyloctyl Salicylate, Diethylhexyl Maleate, Jojoba Esters, Cyclopentasiloxane, C10-30 Cholesterol/Lanosterol Esters, Phenyl Trimethicone, Stearic Acid, Stearyl Alcohol, GlycerylPolymethacrylate, Propylene Glycol, Biosaccharide Gum-1, Sorbitan Stearate, PalmitoylOligopeptide, DipalmitoylHydroxylproline, Hydrolyzed Elastin, Collagen Amino Acids, Hydrolyzed Malt Extract, Hydrolyzed Rice Protein, Ilex Aquifolium (Holly) Leaf Extract, Calluna Vulgaris Flower Extract, CucumisSativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, RuscusAculeatus Root Extract, Echinacea Angustifolia Extract, Camellia Sinensis Leaf Extract, Glycyrrhetinic Acid, HamamelisVirginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hyaluronic Acid, EuphrasiaOfficinalis Extract, Bisabolol, Tocopheryl Acetate, AscorbylPalmitate, RetinylPalmitate, Lecithin, Dimethicone, Dimethicone/Vinyl DimethiconeCrosspolymer, CetearylMethicone, Bis-EthylhexylHydroxydimethoxyBenzylmalonate, PPG-20 Methyl Glucose Ether, PEG-100 Stearate, Polysorbate 60, Sorbitol, Triethanolamine, Alcohol, Caprylyl Glycol, Butylene Glycol, Polyquaternium-24, Sodium Oleanolate, Sodium Ursolate, Phospholipids, PEG-7M, PEG-8, Carbomer, Silica, PVP, Phenoxyethanol, Chlorphenesin, Methylisothiazolinone, Diazolidinyl Urea, Imidazolidinyl Urea, Methylparaben, Disodium EDTA, Trisodium EDTA, Yellow 5, Red 4
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREVENTAGE FIRMING DEFENSE CREME NORMAL/DRY MERLE NORMAN
avobenzone, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-121 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) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIETHYLHEXYL MALEATE (UNII: C2F7JHI12L) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 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) GINKGO (UNII: 19FUJ2C58T) RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q) ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ENOXOLONE (UNII: P540XA09DR) HYALURONIC ACID (UNII: S270N0TRQY) EUPHRASIA STRICTA (UNII: C9642I91WL) LEVOMENOL (UNII: 24WE03BX2T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) DIMETHICONE (UNII: 92RU3N3Y1O) BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV) PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K) PEG-100 STEARATE (UNII: YD01N1999R) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITOL (UNII: 506T60A25R) TROLAMINE (UNII: 9O3K93S3TK) ALCOHOL (UNII: 3K9958V90M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 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) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) IMIDUREA (UNII: M629807ATL) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) EDETATE TRISODIUM (UNII: 420IP921MB) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-121-02 1 in 1 BOX 08/17/2012 1 NDC:57627-121-01 56 g 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 08/17/2012 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(57627-121)
