THE SPF 18 FLUID TINT- octinoxate, homosalate, and avobenzone lotion
THE SPF 18 FLUID TINT by
Drug Labeling and Warnings
THE SPF 18 FLUID TINT by is a Otc medication manufactured, distributed, or labeled by MAX HUBER RESEARCH LAB INC, ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), Estee Lauder Inc., ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, Pennsylvania Logistics Center. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- 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)
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