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

LA MER THE REPARATIVE FACE SUN Broad Spectrum SPF 30 by

Drug Labeling and Warnings

LA MER THE REPARATIVE FACE SUN Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by MAX HUBER RESEARCH LAB INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. 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 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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/11/2012

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

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

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

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(65966-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(65966-011)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(65966-011)

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

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

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(65966-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(65966-011)