Label: THE SPF 18 FLUID TINT- octinoxate, homosalate, and avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 65966-918-01 - Packager: MAX HUBER RESEARCH LAB INC
- 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 June 12, 2012
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- WARNING
- ACTIVE INGREDIENTS
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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
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INGREDIENTS AND APPEARANCE
THE SPF 18 FLUID TINT
octinoxate, homosalate, and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65966-918 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3.5 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:65966-918-01 1 in 1 CARTON 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/01/2005 Labeler - MAX HUBER RESEARCH LAB INC (926708694) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(65966-918) , REPACK(65966-918) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(65966-918) , RELABEL(65966-918) , REPACK(65966-918) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(65966-918) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(65966-918) , RELABEL(65966-918) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(65966-918) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(65966-918) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(65966-918) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(65966-918) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(65966-918) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(65966-918) , RELABEL(65966-918) , REPACK(65966-918) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(65966-918) , RELABEL(65966-918) , REPACK(65966-918) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(65966-918) , RELABEL(65966-918) , REPACK(65966-918) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(65966-918) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(65966-918) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(65966-918) , RELABEL(65966-918)
