![JANE SEYMOUR OIL-FREE TINTED MOISTURIZER WITH SPF 55 (OXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE) LIQUID [GUTHY-RENKER, LLC.]](https://medic.hrt.org//dailymed/images/ec8411f0-c6cb-4631-a470-20a0fb50241e/jan00-0000-01.jpg)
| NDC | 11410-412-01 |
| Set ID | ec8411f0-c6cb-4631-a470-20a0fb50241e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Guthy-Renker, LLC. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- DIRECTIONS:
- ACTIVE INGREDIENTS:
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INACTIVE INGREDIENTS:
Water, Butylene Glycol, PEG-8, Poly-Ethylene, Silica, Dimethicone, Picea Excelsa Wood Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Tocopherol, Methyl Glucose Sesquistearate, Glycerin, Acrylates/C10-30 Alkyl Acrylates Cross-Polymer, Bentonite, Sodium Hydroxide, Sodium Polyacrylate, Disodium EDTA, Xanthan Gum, Ammonium Poly-Acrylate, Phenoxyethanol, Chlorphenesin, Ethylhexylglycerin, Alumina, Iron oxides (C.I. 77492), Titanium Dioxide, Iron Oxides (C.I. 77491), Iron Oxides (C.I. 77499)
Distributed by: Guthy-Renker®, LLC
P.O. Box 14383
Palm Desert, CA 92255-4383
London UK SW1Y 4HH,
Sydney, Australia 2138,
Auckland, New Zealand,
Toronto, Ontario M1X 1E7M050903
ND.0076 - Principal Display Panel – 30 mL Tube
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INGREDIENTS AND APPEARANCE
JANE SEYMOUR OIL-FREE TINTED MOISTURIZER WITH SPF 55
oxybenzone, octocrylene, octisalate, avobenzone, homosalate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-412 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 60 uL in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 20 uL in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 uL in 1 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 uL in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 100 uL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) PICEA ABIES WOOD (UNII: 72GZ8K8996) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) BENTONITE (UNII: A3N5ZCN45C) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-412-01 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/04/2011 Labeler - Guthy-Renker, LLC. (608315453) Registrant - AMCOL Health & Beauty Solutions, Incorporated (872684803) Establishment Name Address ID/FEI Business Operations AMCOL Health & Beauty Solutions, Incorporated 872684803 MANUFACTURE Establishment Name Address ID/FEI Business Operations Thibiant, International, Inc. 083913913 MANUFACTURE
