ADVANCED MARINE BIOLOGY DAY SPF 20 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate cream

Advanced Marine Biology Day SPF 20 by

Drug Labeling and Warnings

Advanced Marine Biology Day SPF 20 by is a Otc medication manufactured, distributed, or labeled by Temmentec Ag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Advanced Marine Biology Day Cream

Firms Repairs Protects

Creme Biologie Marine Acancee Jour

Raffermit Repare Protege

SPF 20

La Prairie Switzerland

50 ml / 1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

ADVANCED MARINE BIOLOGY DAY SPF 20  LA PRAIRIE GROUP AG
avobenzone, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68807-305
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 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

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: 68807-305-02	1 in 1 BOX
1	NDC: 68807-305-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

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(68807-305)