Label: PREVENTAGE FIRMING DEFENSE CREME NORMAL/ OILY BROAD SPECTRUM SPF 15- avobenzone, octocrylene cream
- NDC Code(s): 57627-186-01
- Packager: Merle Norman Cosmetics
- 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 17, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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
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INACTIVE INGREDIENT
Inactive (non-medicinal) ingredients: Aqua/Water/Eau, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hamamelis Virginiana (Witch Hazel) Bark/leaf/twig Extract, Glyceryl Polymethacrylate, Dipalmitoyl hydroxyproline, octyldodecyl Neopentanoate, Phenyl Trimethicone, PPG-20 Methyl Glucose Ether, Hydrolyzed Malt Extract, Propylene Glycol, Myristyl Lactate, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol, Alcohol, Triethanolamine, Phenoxyethanol, Biosaccharide Gum-1, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Bisabolol, Carbomer, Dimethicone, Hydrolyzed Elastin, PEG-100 Stearate, Glycerin, PEG-8, Sorbitol, Caprylyl Glycol, Myristyl Alcohol, Tocopheryl Acetate, Calluna Vulgaris Flower Extract, Collagen Amino Acids, PEG-7M, Polysorbate 60, Ethylhexylglycerin, Phospholipids, Silica, Cucumis Sativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, Glycyrrhetinic Acid, Ruscus Aculeatus Root Extract, Hexylene Glycol, Lectithin, Tetrasodium EDTA, Hydrolyzed Rice Protein, Disodium EDTA, Camellia Sinensis Leaf Extract, PVP, Echinacea Angustifolia Extract, Chlorphenesin, Hyaluronic Acid, Polyquaternium-24, Ilex Aquifolium (Holly) Leaf Extract, Sodium Oleanolate, Sodium Ursolate, Ascorbyl Palmitate, Euphrasia Officinalis Extract, Retinyl Palmitate, Palmitoyl Hexapeptide-12.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREVENTAGE FIRMING DEFENSE CREME NORMAL/ OILY BROAD SPECTRUM SPF 15
avobenzone, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-186 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.9 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.4 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SORBITOL (UNII: 506T60A25R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MYRISTYL ALCOHOL (UNII: V42034O9PU) CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV) POLYETHYLENE OXIDE 300000 (UNII: 4QIB4U4CQR) EDETATE DISODIUM (UNII: 7FLD91C86K) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ILEX AQUIFOLIUM LEAF (UNII: 9Z32IEA9F7) ASCORBYL PALMITATE (UNII: QN83US2B0N) EUPHRASIA STRICTA (UNII: C9642I91WL) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 60 (UNII: CAL22UVI4M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) ALCOHOL (UNII: 3K9958V90M) LEVOMENOL (UNII: 24WE03BX2T) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PEG-100 STEARATE (UNII: YD01N1999R) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) SODIUM URSOLATE (UNII: NV5D25VL1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K) MYRISTYL LACTATE (UNII: 1D822OC34X) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) HEXYLENE GLYCOL (UNII: KEH0A3F75J) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GINKGO (UNII: 19FUJ2C58T) ENOXOLONE (UNII: P540XA09DR) GREEN TEA LEAF (UNII: W2ZU1RY8B0) RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q) POVIDONE (UNII: FZ989GH94E) ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) CHLORPHENESIN (UNII: I670DAL4SZ) HYALURONIC ACID (UNII: S270N0TRQY) EDETATE SODIUM (UNII: MP1J8420LU) CUCUMBER (UNII: YY7C30VXJT) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-186-01 56 g in 1 CARTON; Type 0: Not a Combination Product 01/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/17/2022 Labeler - Merle Norman Cosmetics (008479388) Registrant - Merle Norman Cosmetics (008479388)
