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

Principal Display Panel - 50 ml Bottle Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	05/05/2013

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

Registrant - Estee Lauder Companies Inc. (790802086)

Name	Address	ID/FEI	Business Operations
Establishment
PALC		078364654	label(65966-016) , pack(65966-016)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics Ltd.		204132062	pack(65966-016) , label(65966-016)

Name	Address	ID/FEI	Business Operations
Establishment
Whitman Laboratories Ltd.		216866277	manufacture(65966-016) , pack(65966-016) , label(65966-016)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder N.V.		370151326	manufacture(65966-016) , pack(65966-016) , label(65966-016)

Name	Address	ID/FEI	Business Operations
Establishment
The Estee Lauder Inc		802599436	manufacture(65966-016) , pack(65966-016) , label(65966-016)

Name	Address	ID/FEI	Business Operations
Establishment
Northtec LLC		943871157	pack(65966-016) , label(65966-016)

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