LINE INTERCEPTION POWER DUO DAY CREAM SUNCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene cream

Line Interception Power Duo Day Cream Suncreen by

Drug Labeling and Warnings

Line Interception Power Duo Day Cream Suncreen 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 2.7% .............

Homosalate 9.0% .............   Sunscreen

Octisalate   4.5% ............

Octocrylene 9.0% ...........

PURPOSE

Helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions

• apply daily after cleansing and toning
• smooth over face & throat
• apply liberally 15 minutes before sun exposure
• children und 6 months of age: Ask a doctor
• reapply at least every 2 hours
• use a water resistan sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sunincreases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and oher sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive Ingredients:

Water (Aqua), Glycerin, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Butylene Glycol, Microcrystalline Cellulose, Polymethylsilsquioxane, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense Extract, Carnosine, Lactic Acid, Glycolic Acid, Palmitoyl Hexapeptide-52, Palmitoyl Heptapeptide-18, Dipeptide Diaminobutyroyl Benzylamide Diacetate, Urea, Sodium Stearoyl Lactylate, Saccharide Hydrolysate, Alanine, Glycine, Magnesium Aspartate, Creatine, Pinus Pinaster Bark/Bud Extract, Diglycerin, Ascorbic Acid, Lauryl Lactate, Tocopherol, Lactobaillus Ferment, Diethylhexyl Syringylidenemalonate, Saccharomyces Cerevisiae Extract, Ascorbyl Palmitate, Disodium EDTA, Behenyl Alcohol, C20-22 Alcohol, Sodium Hydroxide, Citric Acid, Dimethicone, Caprylic/Capric Triglyceride, PEG-8, Isodecyl Neopentanoate, Polyglyceryl-10 Pentastearate, Diisopropyl Sebacate, Ethylhexylglycerin, C20-22 Alkyl Phosphate, Steareth-21, Cellulose Gum, Polyvinyl Alcohol, Xanthan Gum, Fragrance (Parfum) Linalool, Citronellol, Hydroxycitronellal, Hexyl Cinnamal, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Phenoxyethanol, Potassium Sorbate, Sodium Dehydroacetate, Dehydroacetic Acid, Reg 4 (CI 14700), Yellow 5 (CI 19140)

PRINCIPAL DISPLAY PANEL

La Prairie

Line Interception Anti-Wrinkle Day - Night Intervention

Day Cream

Sunscreen

Broad Spectrum

SPF30

50 ml e / 1.7 FL. OZ.

INGREDIENTS AND APPEARANCE

LINE INTERCEPTION POWER DUO DAY CREAM SUNCREEN  BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68807-326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 kg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.0 g  in 100 kg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 kg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.0 g  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCOPROTEIN HORMONES ALPHA CHAIN (UNII: 8YJ68CQ409)
ASIAN GINSENG (UNII: CUQ3A77YXI)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
CARNOSINE (UNII: 8HO6PVN24W)
LACTIC ACID (UNII: 33X04XA5AT)
GLYCOLIC ACID (UNII: 0WT12SX38S)
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE (UNII: 38H206R00R)
UREA (UNII: 8W8T17847W)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
INVERT SUGAR (UNII: ED959S6ACY)
ALANINE (UNII: OF5P57N2ZX)
GLYCINE (UNII: TE7660XO1C)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
CREATINE (UNII: MU72812GK0)
DIGLYCERIN (UNII: 3YC120743U)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
LAURYL LACTATE (UNII: G5SU0BFK7O)
TOCOPHEROL (UNII: R0ZB2556P8)
LACTOBACILLUS REUTERI (UNII: 9913I24QEE)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DOCOSANOL (UNII: 9G1OE216XY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
STEARETH-21 (UNII: 53J3F32P58)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYVINYL ALCOHOL (UNII: 532B59J990)
XANTHAN GUM (UNII: TTV12P4NEE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
GERANIOL (UNII: L837108USY)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
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: 68807-326-11	60 kg in 1 DRUM; Type 0: Not a Combination Product	04/14/2016
2	NDC: 68807-326-22	120 kg in 1 DRUM; Type 0: Not a Combination Product	04/14/2016
3	NDC: 68807-326-33	78.4 kg in 1 DRUM; Type 0: Not a Combination Product	04/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/14/2016

Labeler - Temmentec AG (480586411)

Registrant - Temmentec AG (480586411)

Establishment
Name	Address	ID/FEI	Business Operations
Temmentec AG		480586411	manufacture(68807-326)