RE NUTRIV RADIANT UV BASE BROAD SPECTRUM SPF 50- homosalate , octyl salicylate, avobenzone, oxybenzone, octocrylene lotion 
ESTEE LAUDER INC

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 FACTS

ACTIVE INGREDIENTS:

AVOBENZONE 3.00%

HOMOSALATE 5.00%

OCTOCRYLENE 2.70%

OCTISALATE 5.00%

OXYBENZONE 3.00%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN

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.

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

For sunscreen use:

    * apply liberally 15 minutes before sun exposure
    * reapply at least every two hours
    * use a water resistant sunscreen if swimming or sweating
    * 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:
          o limit time in the sun, especially from 10 a.m.–2 p.m.
          o wear long-sleeved shirts, pants, hats and sunglasses
    * children under 6 months of age: ask a doctor

INACTIVE INGREDIENTS

WATER\AQUA\EAU [] BUTYLOCTYL SALICYLATE [] METHYL TRIMETHICONE [] NEOPENTYL GLYCOL DIHEPTANOATE [] ALEURITES MOLUCCANA (KUKUI) SEED OIL [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] PEG-100 STEARATE [] BUTYLENE GLYCOL [] DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE [] GLYCERYL STEARATE [] ALGAE EXTRACT [] LAMINARIA OCHROLEUCA EXTRACT [] LAMINARIA DIGITATA EXTRACT [] CETYL ALCOHOL [] CAFFEINE [] HYDROLYZED WHEAT PROTEIN [] VP/EICOSENE COPOLYMER [] PEARL POWDER [] GOLD [] SODIUM HYALURONATE [] ERGOTHIONEINE [] STEARIC ACID [] DEHYDROXANTHAN GUM [] POTASSIUM CETYL PHOSPHATE [] ETHYLHEXYLGLYCERIN [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] SACCHARIDE ISOMERATE [] CAPRYLYL GLYCOL [] GLYCERIN [] SORBITOL [] SILICA [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] FRAGRANCE (PARFUM) [] DISODIUM EDTA [] CITRIC ACID [] PHENOXYETHANOL [] SODIUM DEHYDROACETATE [] MICA [] TITANIUM DIOXIDE (CI 77891) [] RED 33 (CI 17200) [] BLUE 1 (CI 42090)

OTHER INFORMATION

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL:

ESTEE LAUDER

RE-NUTRIV

RADIANT UV BASE

BROAD SPECTRUM

SPF 50



1FL OZ LIQ / 30 ML




ESTEE LAUDER DIST
NY, NY 10022

FOLDING CARTON



RE NUTRIV RADIANT UV BASE  BROAD SPECTRUM SPF 50
homosalate , octyl salicylate, avobenzone, oxybenzone, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.0 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.0 nmol  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
KUKUI NUT (UNII: J87WJ3E7VW)  
PEG-100 STEARATE (UNII: YD01N1999R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
NORI (UNII: 477TV3P5UX)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CAFFEINE (UNII: 3G6A5W338E)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-017-011 in 1 CARTON
1NDC:11559-017-0230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2012
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol959338336manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone943871157manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.244669714manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Centre208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center (PALC)078364654repack, relabel

Revised: 4/2012
Document Id: 041b854b-9555-4aa2-bcca-badf10d5886f
Set id: 413949ef-08c0-412a-8fdf-c8c27093d7c3
Version: 1
Effective Time: 20120424
 
ESTEE LAUDER INC