MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25- octinoxate, octisalate, titanium dioxide, and zinc oxide cream

MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25 by

Drug Labeling and Warnings

MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, 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

Octinoxate 7.5%
Octisalate 4.5%
Titanium dioxide 3.8%
Zinc oxide 3.6%

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:
  • 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 c12-15 alkyl benzoate caprylyl methicone neopentyl glycol diheptanoate butylene glycol pentylene glycol glycerin polyglyceryl-10 pentastearate hydrogenated lecithin behenyl alcohol peg-100 stearate sucrose laminaria saccharina extract cucumis sativus (cucumber) fruit extract aloe barbadensis leaf water hordeum vulgare (barley) extract\extrait d'orge caffeine tocopheryl acetate isohexadecane lecithin sodium stearoyl lactylate propylene glycol dicaprate sodium hyaluronate helianthus annuus (sunflower) seedcake trehalose isostearic acid polyhydroxystearic acid polysorbate 80 dimethicone xanthan gum polyethylene acrylamide/sodium acryloyldimethyltaurate copolymer silica disodium edta tetrasodium edta bht phenoxyethanol [+/- titanium dioxide (ci 77891) iron oxides (ci 77491) iron oxides (ci 77492) iron oxides (ci 77499)] [iln45300]

Other information

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

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

hydration

CLINIQUE

moisture surge

sheertint hydrator
broad spectrum
SPF 25

MIMETIC-SHADE™ TECHNOLOGY

1.4 FL.OZ.LIQ./40 ml e

INGREDIENTS AND APPEARANCE

MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25 
octinoxate, octisalate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.082 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.049 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.041 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.039 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
DOCOSANOL (UNII: 9G1OE216XY)
PEG-100 STEARATE (UNII: YD01N1999R)
SUCROSE (UNII: C151H8M554)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
CUCUMBER (UNII: YY7C30VXJT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BARLEY (UNII: 5PWM7YLI7R)
CAFFEINE (UNII: 3G6A5W338E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOHEXADECANE (UNII: 918X1OUF1E)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
TREHALOSE (UNII: B8WCK70T7I)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 49527-074-01	1 in 1 CARTON	10/16/2019
1		40 mL in 1 TUBE; 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	10/16/2019

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-074) , REPACK(49527-074)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-074)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-074)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-074)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-074)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-074) , REPACK(49527-074)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-074) , REPACK(49527-074)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-074)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-074)