CELLULAR RADIANCE EMULSION SPF 30 LA PRAIRIE- avobenzone, octinoxate, octisalate cream

Cellular Radiance Emulsion SPF 30 by

Drug Labeling and Warnings

Cellular Radiance Emulsion SPF 30 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

Octinoxate 7.5% Sunscreen

Octisalate 5.0% Sunscreen

Oxybenzone 3.0% Sunscreen

Uses

helps prevent sunburn

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Directions

apply daily after cleansing and toning

smooth over face and throat

apply liberally 15 minutes before sun exposure

children under 6 months of age: Ask a doctor

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

Inactive Ingredients:

Water (Aqua), C12-15 Alkyl Ethylhexanoate, Cetyl Alcohol, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Sea Water (Maris Aqua), Dimethicone, Behenyl Alcohol, Stearyl Alcohol, Butylene Glycol, Propylene Glycol, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Batyl Alcohol, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Phytosterols,
Salicornia Herbacea Extract, Niacinamide, Hydrolyzed Oat Protein, Alpinia Galanga Leaf Extract, Quartz,
Disodium Adenosine Triphosphate,Tocopherol, Carica Papaya (Papaya) Fruit Extract, Cholesteryl Nonanoate,
Cimicifuga Racemosa Root Extract, Zinc Gluconate, Hydrogenated Lecithin, Trifolium Pratense (Clover) Flower Extract, Copper Gluconate, Gold, PEG-20 Phytosterol, Actinidia Polygama Fruit Extract, Acetyl Heptapeptide, Colloidal Gold, Cholesteryl Oleate, Dimethylmethoxy Chromanyl Palmitate, Corallina Officinalis Extract, Carbomer, Cholsteryl Stearate, Acrylates Copolymer, Boswellia Serrata Resin Extract, Ammonium Acryloyldimethltaurate/VP Copolymer, Phormidium Persicinum Extract, Caprylyl Glycol, Dextran, Magnesium Asparate, Glyceryl Stearate, Disodium EDTA, Xanthan Gum, BHT, Fragrance (Parfum), Linalool, Hexyl Cinnamal, Hydroxycitronellal, Alpha-Isomethyl Ionone, Geraniol, Citronellol, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Eugenol, Benzyl Salicylate, Limonene, Phenoxyethanol, Sorbic Acid, Methylparaben, Mica, Titanium Dioxide (CI 77891), Red (CI 14700), Yellow 5 (CI 19140)

PRINCIPAL DISPLAY PANEL

Cellular Radiance Emulsion

Emulsion Cellulaire Radiance

Sunscreen Creme Solaire

SPF 30

La Prairie Switzerland

50 ml/ 1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

CELLULAR RADIANCE EMULSION SPF 30  LA PRAIRIE
avobenzone, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68807-320
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	75 mg  in 100 kg
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 100 kg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DIMETHICONE (UNII: 92RU3N3Y1O)
DOCOSANOL (UNII: 9G1OE216XY)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BATILOL (UNII: 39YR661C4U)
ASIAN GINSENG (UNII: CUQ3A77YXI)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
SALICORNIA EUROPAEA (UNII: 6ADL50JAKW)
NIACINAMIDE (UNII: 25X51I8RD4)
ALPINIA GALANGA LEAF (UNII: GD58MI8TU5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)
TOCOPHEROL (UNII: R0ZB2556P8)
PAPAYA (UNII: KU94FIY6JB)
CHOLESTERYL NONANOATE (UNII: 4313O7P4XW)
BLACK COHOSH (UNII: K73E24S6X9)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
COPPER GLUCONATE (UNII: RV823G6G67)
ACTINIDIA POLYGAMA FRUIT (UNII: CJA97047JF)
GOLD (UNII: 79Y1949PYO)
CHOLESTERYL OLEATE (UNII: 3DPK9KFN2M)
CORALLINA OFFICINALIS (UNII: 4004498D06)
CARBOMER 934 (UNII: Z135WT9208)
CHOLESTERYL STEARATE (UNII: I1Q82N9DYQ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PHORMIDIUM PERSICINUM (UNII: ZA983U4810)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DEXTRAN 1 (UNII: I8LHQ0D645)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LINALOOL, (+)- (UNII: F4VNO44C09)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)
EUGENOL (UNII: 3T8H1794QW)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LIMONENE, (-)- (UNII: 47MAJ1Y2NE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)
METHYLPARABEN (UNII: A2I8C7HI9T)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68807-320-11	78.4 kg in 1 DRUM; Type 0: Not a Combination Product	01/11/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/11/2013

Labeler - Temmentec Ag (480586411)

Registrant - Temmentec Ag (480586411)

Establishment
Name	Address	ID/FEI	Business Operations
Temmentec Ag		480586411	manufacture(68807-320)