Label: SIMPLE PROTECTING LIGHT MOISTURIZER SPF 15- avobenzone, ensulizole, octicsalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 64942-1290-1, 64942-1290-2, 64942-1290-3, 64942-1290-4 - Packager: CONOPCO Inc. d/b/a Unilever
- 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 February 19, 2013
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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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
· limit time in the sun, especially from 10a.m. - 2p.m.
· wear long-sleeved shirts, pants, hats, and sunglasses.
· re-apply at least every 2 hours.
· use a water resistant sunscreen if swimming or sweating.
· Children under 6 months of age: Ask a doctor. - INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIMPLE PROTECTING LIGHT MOISTURIZER SPF 15
avobenzone, ensulizole, octicsalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64942-1290 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g in 100 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 1.0 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCOL STEARATE (UNII: 0324G66D0E) PEG-100 STEARATE (UNII: YD01N1999R) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) POTASSIUM STEARATE (UNII: 17V812XK50) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL ALCOHOL (UNII: 936JST6JCN) XANTHAN GUM (UNII: TTV12P4NEE) STEARAMIDE AMP (UNII: U3K8640346) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) PANTHENOL (UNII: WV9CM0O67Z) ALLANTOIN (UNII: 344S277G0Z) LEVOMENOL (UNII: 24WE03BX2T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64942-1290-2 1 in 1 CARTON 1 NDC:64942-1290-1 124 mL in 1 BOTTLE, PLASTIC 2 NDC:64942-1290-4 1 in 1 PACKAGE 2 NDC:64942-1290-3 7.4 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/01/2013 Labeler - CONOPCO Inc. d/b/a Unilever (001375088) Establishment Name Address ID/FEI Business Operations Klocke of America, Inc. 013950402 pack(64942-1290)