Label: SIMPLE VITAL VITAMIN DAY CREAM SPF 15- homosalate, octisalate, avobenzone, and octocrylene emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 64942-1244-1, 64942-1244-2 - Packager: CONOPCO Inc. d/b/a Unilever
- Category: HUMAN OTC DRUG LABEL
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 February 21, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
Apply liberally and evenly to face and neck 15 minutes before sun exposure.
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 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.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Children under 6 months: Ask a doctor.
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INACTIVE INGREDIENT
Inactive ingredients
Water (Aqua, Eau) Homosalate Glycerin C12-15 Alkyl Benzoate Ethylhexyl Salicylate Butyl Methoxydibenzoylmethane Silica Octocrylene Pentylene Glycol Cetearyl Alcohol Steareth-21 Steareth-2 Phenoxyethanol Arachidyl Alcohol Polyacrylamide Caprylyl Glycol Behenyl Alcohol C13-14 Isoparaffin Disodium EDTA Xanthan Gum Cetearyl Glucoside Arachidyl Glucoside Allantoin Tocopheryl Acetate Bisabolol Panthenol Laureth-7 Triethanolamine Methylisothiazolinone - QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIMPLE VITAL VITAMIN DAY CREAM SPF 15
homosalate, octisalate, avobenzone, and octocrylene emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64942-1244 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.12 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 g Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.027 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PENTYLENE GLYCOL (UNII: 50C1307PZG) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PANTHENOL (UNII: WV9CM0O67Z) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARETH-21 (UNII: 53J3F32P58) STEARETH-2 (UNII: V56DFE46J5) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DOCOSANOL (UNII: 9G1OE216XY) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) ALLANTOIN (UNII: 344S277G0Z) LEVOMENOL (UNII: 24WE03BX2T) LAURETH-7 (UNII: Z95S6G8201) TROLAMINE (UNII: 9O3K93S3TK) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64942-1244-2 1 in 1 CARTON 1 NDC:64942-1244-1 50 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2012 Labeler - CONOPCO Inc. d/b/a Unilever (001375088)
