Label: AVON ELEMENTS SKIN REVITALIZE INSTANT RADIANCE- octinoxate, oxybenzone, homosalate, avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0302-1, 10096-0302-2, 10096-0302-3 - Packager: New Avon LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- apply generously and evenly 15 minutes before sun exposure
- children under 6 month of age:ask a doctor
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
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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
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients:
water/eau, propanediol, glycerin, DI-C12-15 alkyl fumarate, dilauryl thiodipropionate, PEG-8, steareth-2, silica, ethylhexyl isononanoate, steareth-21, aronia melanocarpa fruit juice, zizyphus jujuba fruit extract, petasites hybridus leaf extract, saccharomyces/platinum ferment, stearyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, silica dimethyl silylate, polyester-1, PEG-200, polyurethane-40, carbomer, tromethamine, disodium EDTA, 1,2-hexanediol, caprylyl glycol, parfum/fragrance, iron oxides, mica/CI 77019, titanium dioxide/CI 77891. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AVON ELEMENTS SKIN REVITALIZE INSTANT RADIANCE
octinoxate, oxybenzone, homosalate, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 35 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 30 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0302-2 1 in 1 CARTON 1 NDC:10096-0302-1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10096-0302-3 1.1 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2013 Labeler - New Avon LLC (080143520) Establishment Name Address ID/FEI Business Operations Avon Products, Inc 005149471 manufacture(10096-0302)