Label: ADVANCED MARINE BIOLOGY DAY SPF 20 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68807-319-11 - Packager: Temmentec Ag
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 25, 2016
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 3.0% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5.0% Sunscreen
Uses
- helps prevent sunburn
- for skin that burns easily
- provides moderate protection against sunburn
- higher SPF gives more sunburn protection
Keep out of reach of children. Do not use on children.
Discontinue use if signs of irritation occur
Warnings
For External use only
Avoid Contact with eyes
If product gets into eyes, rinse thoroughly with water
Directions
- apply daily after cleansing and toning
- smooth over face and throat
- apply evenly before sun exposure
- reapply as needed or after towel drying, swimming or perspiring
Inactive Ingredients
Water (Aqua), Glycerin, Octyldodecyl Neopentanoate, Butyrospermum Parkii (Shea Butter), PEG-40 Stearate, Butylene Glycol, Glyceryl Stearate, Cyclopentasiloxane, Cetyl Alcohol, C12-15 Alkyl Benzoate, Hydrogenated Polyisobutene, Ammonium Acryloyldimethyltaurate/VP Copolymer, Glycoproteins*, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Chondrus Crispus (Carrageenan) Extract, Sodium Hyaluronate, Disodium EDTA, Saccharomyces/Carrageenan Extract/Sarcodiotheca Gaudichaudii Extract Ferment, Acetyl Hexapeptide-20, Panthenol, Dimethicone, Palmaria Palmata Extract, Sodium Carbomer, Caprylic/Capric Triglyceride, Limonium Gerberi Extract, Silica, Acrylates Copolymer, Tripleurospermum Maritimum Extract, HDI/Trimethylol Hexyllactone Crosspolymer, Crambe Maritima Extract, Dipropylene Glycol Dibenzoate, Inula Crithmoide Extract, Caprylyl Glycol, Propyl Gallate, Aster Marittima/Tripolium Extract, PPG-15 Stearyl Ether Benzoate, Thalassiosira Pseudonana Extract, Carbomer, Dextran, Fragrance (Parfum), Phenoxyethanol, Sorbic Acid, Potassium Sorbate, Yellow 5 (CI 19140), Blue 1 (CI 42090)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVANCED MARINE BIOLOGY DAY SPF 20 LA PRAIRIE GROUP AG
avobenzone, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-319 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 kg OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 kg OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 kg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) SHEA BUTTER (UNII: K49155WL9Y) PEG-40 STEARATE (UNII: ECU18C66Q7) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CETYL ALCOHOL (UNII: 936JST6JCN) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) ASIAN GINSENG (UNII: CUQ3A77YXI) CHONDRUS CRISPUS (UNII: OQS23HUA1X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) EDETATE DISODIUM (UNII: 7FLD91C86K) PANTHENOL (UNII: WV9CM0O67Z) DIMETHICONE (UNII: 92RU3N3Y1O) DULSE (UNII: 7832HOY4ZQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LIMONIUM GERBERI FLOWERING TOP (UNII: V4O4C05BJ2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PROPYL GALLATE (UNII: 8D4SNN7V92) PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68807-319-11 78.4 kg in 1 DRUM; Type 0: Not a Combination Product 01/16/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/16/2013 Labeler - Temmentec Ag (480586411) Registrant - Temmentec Ag (480586411) Establishment Name Address ID/FEI Business Operations Temmentec Ag 480586411 manufacture(68807-319)