LA MER THE REPARATIVE FACE SUN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
MAX HUBER RESEARCH LAB INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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LA MER THE REPARATIVE FACE SUN LOTION
Broad Spectrum SPF 30

Drug Facts

Active ingredients

Avobenzone 3.00%
Homosalate 5.00%
Octisalate 5.00%
Octocrylene 2.70%
Oxybenzone 2.50%

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

Inactive ingredients

water\aqua\eau • dimethicone • butyloctyl salicylate • neopentyl glycol diheptanoate • butylene glycol • peg-100 stearate • dipentaerythrityl tri-polyhydroxystearate • silica • lauryl peg-9 polydimethylsiloxyethyl dimethicone • butyrospermum parkii (shea butter) • methyl trimethicone • phenyl trimethicone • trisiloxane • glyceryl stearate • 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 • rosmarinus officinalis (rosemary) extract • citrus aurantifolia (lime) peel extract • cucumis sativus (cucumber) fruit extract • pyrus malus (apple) fruit extract • scutellaria baicalensis root extract • plankton extract • laurdimonium hydroxypropyl hydrolyzed soy protein • malachite • acetyl hexapeptide-8 • caffeine • arginine ferulate • lecithin • cholesterol • yeast extract\faex\extrait de levure • sorbitol • glycerin • trehalose • phytosphingosine • polyquaternium-51 • styrene/acrylates copolymer • cetyl alcohol • vp/eicosene copolymer • polysilicone-11 • sucrose • urea • caprylyl glycol • ethylhexylglycerin • saccharide isomerate • caprylic/capric triglyceride • ammonium acryloyldimethyltaurate/vp copolymer • sodium pca • sodium hyaluronate • dehydroxanthan gum • peg-8 laurate • tocopheryl acetate • citric acid • tourmaline • propyl gallate • xanthan gum • ascorbyl tocopheryl maleate • stearic acid • nordihydroguaiaretic acid • alcohol denat. • fragrance (parfum) • hexylene glycol • disodium edta • sodium dehydroacetate • phenoxyethanol • hydroxycitronellal • linalool • hexyl cinnamal • amyl cinnamal • benzyl benzoate • coumarin • limonene • citronellol • geraniol • citral • mica <iln39596>

Other information

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

MAX HUBER RESEARCH LABS INC., DIST.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

SOLEIL DE LA MER™

LA MER

the reparative face sun lotion
broad spectrum spf 30

1.7 fl. oz./oz. liq./50 ml e

LA MER THE REPARATIVE FACE SUN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65966-011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-100 STEARATE (UNII: YD01N1999R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TRISILOXANE (UNII: 9G1ZW13R0G)
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)
ROSEMARY (UNII: IJ67X351P9)
LIME PEEL (UNII: 544EQK5Q0W)
CUCUMBER (UNII: YY7C30VXJT)
APPLE (UNII: B423VGH5S9)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
CAFFEINE (UNII: 3G6A5W338E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
TREHALOSE (UNII: B8WCK70T7I)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CETYL ALCOHOL (UNII: 936JST6JCN)
SUCROSE (UNII: C151H8M554)
UREA (UNII: 8W8T17847W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PEG-8 LAURATE (UNII: 762O8IWA10)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYL GALLATE (UNII: 8D4SNN7V92)
XANTHAN GUM (UNII: TTV12P4NEE)
ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)
STEARIC ACID (UNII: 4ELV7Z65AP)
MASOPROCOL (UNII: 7BO8G1BYQU)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
BENZYL BENZOATE (UNII: N863NB338G)
COUMARIN (UNII: A4VZ22K1WT)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
CITRAL (UNII: T7EU0O9VPP)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65966-011-01	1 in 1 CARTON	11/11/2012
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 NOT FINAL	part352	11/11/2012	07/26/2021

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

Registrant - Estee Lauder Companies Inc. (790802086)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COMPANY, THE		828534516	REPACK(65966-011) , RELABEL(65966-011)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(65966-011)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics Ltd.		202952982	MANUFACTURE(65966-011) , REPACK(65966-011) , RELABEL(65966-011)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder N.V.		370151326	MANUFACTURE(65966-011) , REPACK(65966-011) , RELABEL(65966-011)

Name	Address	ID/FEI	Business Operations
Establishment
Len-Ron Manufacturing Division of Aramis Inc.		809771152	MANUFACTURE(65966-011) , REPACK(65966-011) , RELABEL(65966-011)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC INC		943871157	REPACK(65966-011) , RELABEL(65966-011)

Name	Address	ID/FEI	Business Operations
Establishment
PADC 1		949264774	REPACK(65966-011) , RELABEL(65966-011)

Name	Address	ID/FEI	Business Operations
Establishment
Whitman Laboratories Ltd.		216866277	MANUFACTURE(65966-011) , REPACK(65966-011) , RELABEL(65966-011)

Revised: 7/2021

Document Id: a3aeb137-3e99-4839-b402-3daba44d12b1

Set id: 757bb6a5-7ccc-452e-8d47-0e6f2f0df690

Version: 3

Effective Time: 20210726

MAX HUBER RESEARCH LAB INC

LA MER THE REPARATIVE FACE SUN LOTION Broad Spectrum SPF 30