LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID by

Drug Labeling and Warnings

LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID by is a Otc medication manufactured, distributed, or labeled by MAX HUBER RESEARCH LAB INC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

AVOBENZONE 3.00%
HOMOSALATE 5.00%
OCTISALATE 5.00%
OCTOCRYLENE 2.70%
OXYBENZONE 3.00%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

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.

Stop use and ask a doctor if rash occurs.

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

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply every two hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases 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 other sun protection measures including:
  • – limit time in the sun, especially from 10 a.m. – 2 p.m.
  • – wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Ingredients

WATER\AQUA\EAU BUTYLOCTYL SALICYLATE METHYL TRIMETHICONE NEOPENTYL GLYCOL DIHEPTANOATE ALEURITES MOLUCCANA (KUKUI) SEED OIL LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE PEG 100 STEARATE BUTYLENE GLYCOL GLYCERYL STEARATE DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE POTASSIUM CETYL PHOSPHATE ALGAE (SEAWEED) EXTRACT SESAMUM INDICUM (SESAME) SEED OIL MEDICAGO SATIVA (ALFALFA) SEED POWDER HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL SODIUM GLUCONATE COPPER GLUCONATE CALCIUM GLUCONATE MAGNESIUM GLUCONATE ZINC GLUCONATE TOCOPHERYL SUCCINATE NIACIN SESAMUM INDICUM (SESAME) SEED POWDER LAMINARIA OCHROLEUCA EXTRACT MALACHITE CAFFEINE SORBITOL SODIUM HYALURONATE CETYL ALCOHOL STEARIC ACID VP/EICOSENE COPOLYMER ETHYLHEXYLGLYCERIN SACCHARIDE ISOMERATE CAPRYLIC/CAPRIC TRIGLYCERIDE CAPRYLYL GLYCOL AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER DEHYDROXANTHAN GUM SODIUM DEHYDROACETATE CITRIC ACID TOURMALINE STYRENE/ACRYLATES COPOLYMER SILICA PEG-8 LAURATE FRAGRANCE (PARFUM) DISODIUM EDTA PHENOXYETHANOL LIMONENE GERANIOL HYDROXYCITRONELLAL LINALOOL CITRONELLOL MICA GREEN 5 (CI 61570) TITANIUM DIOXIDE (CI 77891) <ILN40137>

Other information

Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

LA MER

the broad spectrum
spf 50 UV protecting fluid

1.7 fl. oz. liq./50 ml e

INGREDIENTS AND APPEARANCE

LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65966-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0312 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.052 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.052 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.02808 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.0312 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
KUKUI NUT OIL (UNII: TP11QR7B8R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SESAME OIL (UNII: QX10HYY4QV)
ALFALFA SEED (UNII: 67PHZ58858)
HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SODIUM GLUCONATE (UNII: R6Q3791S76)
COPPER GLUCONATE (UNII: RV823G6G67)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)
NIACIN (UNII: 2679MF687A)
SESAME SEED (UNII: 7Y1255HVXR)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
CAFFEINE (UNII: 3G6A5W338E)
SORBITOL (UNII: 506T60A25R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG-8 LAURATE (UNII: 762O8IWA10)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GERANIOL (UNII: L837108USY)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65966-016-01	1 in 1 CARTON	05/05/2013
1		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 NOT FINAL	part352	05/05/2013

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(65966-016) , REPACK(65966-016)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(65966-016)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(65966-016)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(65966-016)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(65966-016)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(65966-016) , REPACK(65966-016)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(65966-016) , REPACK(65966-016)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(65966-016)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(65966-016)