THE SPF 18 FLUID TINT- octinoxate, homosalate, and avobenzone lotion 
MAX HUBER RESEARCH LAB 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.

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THE SPF 18 FLUID TINT
SUNSCREEN MAKEUP

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children.

ACTIVE INGREDIENTS

OCTINOXATE 7.50% ∙ HOMOSALATE 3.50% ∙ AVOBENZONE 3.00%

INGREDIENTS

WATER\AQUA\EAU ∙ DIMETHICONE ∙ PENTYLENE GLYCOL ∙ BUTYLENE GLYCOL ∙ C12-15 ALKYL BENZOATE ∙ ACRYLATES COPOLYMER ∙ HYDROGENATED LECITHIN ∙ OCTYLDODECYL NEOPENTANOATE ∙ LAMINARIA OCHROLEUCA EXTRACT ∙ CRITHMUM MARITIMUM EXTRACT ∙ CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT ∙ TRITICUM VULGARE (WHEAT) FLOUR LIPIDS ∙ MALACHITE ∙ TOURMALINE ∙ CHOLESTEROL ∙ LINOLEIC ACID ∙ CAPRYLIC/CAPRIC TRIGLYCERIDE ∙ ISOHEXADECANE ∙ SILICA ∙ SYNTHETIC WAX ∙ PVP/HEXADECENE COPOLYMER ∙ DIPROPYLENE GLYCOL DIBENZOATE ∙ PPG-15 STEARYL ETHER BENZOATE ∙ MAGNESIUM ALUMINUM SILICATE ∙ CELLULOSE GUM ∙ XANTHAN GUM ∙ ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER ∙ TOCOPHERYL ACETATE ∙ CHOLETH-24 ∙ CETETH-24 ∙ POLYSORBATE 80 ∙ FRAGRANCE (PARFUM) ∙ DISODIUM EDTA ∙ PHENOXYETHANOL ∙ POTASSIUM SORBATE ∙ LIMONENE ∙ GERANIOL ∙ LINALOOL ∙ HYDROXYCITRONELLAL ∙ CITRONELLOL ∙ BENZYL SALICYLATE ∙ CITRAL ∙ TITANIUM DIOXIDE (CI 77891) ∙ IRON OXIDES (CI 77491, CI 77492, CI 77499) <ILN35019>

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

LA MER

the spf 18 fluid tint

1.7 FL. OZ. LIQ./50 ml e

Principal Display Panel - 50 ml Bottle Carton
THE SPF 18 FLUID TINT 
octinoxate, homosalate, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65966-918
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.5 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
WHEAT (UNII: 4J2I0SN84Y)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHOLETH-24 (UNII: 5UE7I54O43)  
CETETH-24 (UNII: 0EV3Z43Y2I)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
GERANIOL (UNII: L837108USY)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
CITRAL (UNII: T7EU0O9VPP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65966-918-011 in 1 CARTON
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/2005
Labeler - MAX HUBER RESEARCH LAB INC (926708694)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(65966-918) , REPACK(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(65966-918) , RELABEL(65966-918) , REPACK(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(65966-918) , RELABEL(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(65966-918) , RELABEL(65966-918) , REPACK(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(65966-918) , RELABEL(65966-918) , REPACK(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(65966-918) , RELABEL(65966-918) , REPACK(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(65966-918)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(65966-918) , RELABEL(65966-918)

Revised: 6/2012
Document Id: 4eea5e21-1fc9-4259-aeb0-9642cb92477d
Set id: e71b29e5-8495-42c1-84f6-431fea422512
Version: 1
Effective Time: 20120612
 
MAX HUBER RESEARCH LAB INC