LA MER THE SOFT MOISTURE FOUNDATION BROAD SPECTRUM SPF 30- octinoxate and titanium dioxide powder

LA MER THE SOFT MOISTURE FOUNDATION BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

LA MER THE SOFT MOISTURE FOUNDATION BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by MAX HUBER RESEARCH LAB INC, Estee Lauder Companies Inc., ASANUMA CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 5.1%
Titanium Dioxide 6.0%

Purpose

Sunscreen

Use

helps prevent sunburn

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 at least 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:
  • – time in the sun, especially from 10 a.m. – 2 p.m.
  • – long-sleeve shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

TALC SYNTHETIC FLUORPHLOGOPITE METHYL METHACRYLATE CROSSPOLYMER BORON NITRIDE WATER\AQUA\EAU VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER DIMETHICONE ALUMINUM HYDROXIDE DIISOSTEARYL MALATE 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 CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT CODIUM TOMENTOSUM EXTRACT HYDROLYZED CORALLINA OFFICINALIS WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT ACETYL GLUCOSAMINE ERYNGIUM MARITIMUM EXTRACT LAMINARIA DIGITATA EXTRACT GLYCERIN ACETYL HEXAPEPTIDE-8 BUTYLENE GLYCOL HYDROLYZED RICE BRAN PROTEIN SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE BARIUM SULFATE ISOCETYL MYRISTATE METHICONE SQUALANE PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE POLYSORBATE 80 SILICA HYDRATED SILICA ALUMINUM DISTEARATE HYDROGEN DIMETHICONE TOCOPHEROL FRAGRANCE (PARFUM) TETRAHEXYLDECYL ASCORBATE BHT ALCOHOL DENAT. SODIUM DEHYDROACETATE [+/- MICA TITANIUM DIOXIDE (CI 77891) IRON OXIDES (CI 77491) IRON OXIDES (CI 77492) IRON OXIDES (CI 77499) <ILN45895>

Other information

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

PRINCIPAL DISPLAY PANEL - 9.5 g Jar Carton

SKINCOLOR DE LA MER™

LA MER

THE SOFT MOISTURE POWDER FOUNDATION
BROAD SPECTRUM SPF 30

INGREDIENTS AND APPEARANCE

LA MER THE SOFT MOISTURE FOUNDATION BROAD SPECTRUM SPF 30 
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65966-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	5.1 g  in 100 g
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
talc (UNII: 7SEV7J4R1U)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: 657L0NC5MT)
boron nitride (UNII: 2U4T60A6YD)
water (UNII: 059QF0KO0R)
vinyl dimethicone/methicone silsesquioxane crosspolymer (UNII: 9NH1UDD2RR)
dimethicone (UNII: 92RU3N3Y1O)
aluminum hydroxide (UNII: 5QB0T2IUN0)
diisostearyl malate (UNII: QBS8A3XZGQ)
nori (UNII: 477TV3P5UX)
sesame oil (UNII: QX10HYY4QV)
alfalfa seed (UNII: 67PHZ58858)
helianthus annuus seedcake (UNII: 482WYF7XLC)
eucalyptus gum (UNII: 72T9EZC2VX)
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)
lime peel (UNII: 544EQK5Q0W)
codium tomentosum (UNII: B8B45BRU87)
whey (UNII: 8617Z5FMF6)
n-acetylglucosamine (UNII: V956696549)
laminaria digitata (UNII: 15E7C67EE8)
glycerin (UNII: PDC6A3C0OX)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
butylene glycol (UNII: 3XUS85K0RA)
yeast, unspecified (UNII: 3NY3SM6B8U)
barium sulfate (UNII: 25BB7EKE2E)
isocetyl myristate (UNII: 69AX3BRR5N)
methicone (20 cst) (UNII: 6777U11MKT)
squalane (UNII: GW89575KF9)
phytosteryl/isostearyl/cetyl/stearyl/behenyl dimer dilinoleate (UNII: 8N725H4EFN)
polysorbate 80 (UNII: 6OZP39ZG8H)
silicon dioxide (UNII: ETJ7Z6XBU4)
hydrated silica (UNII: Y6O7T4G8P9)
aluminum distearate (UNII: 7P1HP1B9UI)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
alcohol (UNII: 3K9958V90M)
sodium dehydroacetate (UNII: 8W46YN971G)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65966-020-01	1 in 1 CARTON	06/17/2019
1		9.5 g in 1 JAR; 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	06/17/2019

Labeler - MAX HUBER RESEARCH LAB INC (926708694)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(65966-020) , REPACK(65966-020)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(65966-020)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(65966-020)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(65966-020)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(65966-020)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(65966-020) , REPACK(65966-020)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(65966-020) , REPACK(65966-020)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(65966-020)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(65966-020)

Establishment
Name	Address	ID/FEI	Business Operations
ASANUMA CORPORATION		715464975	MANUFACTURE(65966-020)