MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOR- octinoxate, octisalate, titanium dioxide, and zinc oxide cream

MOISTURE SURGE CC by

Drug Labeling and Warnings

MOISTURE SURGE CC by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, 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

Octinoxate 7.5%
Octisalate 5.0%
Titanium dioxide 5.2%
Zinc oxide 3.2%

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 squalane octyldodecyl neopentanoate butylene glycol propanediol glyceryl stearate behenyl alcohol peg-40 stearate polyglyceryl-10 pentastearate aloe barbadensis leaf water thermus thermophillus ferment trehalose caffeine glycerin linoleic acid lecithin stearic acid hydrogenated lecithin sorbitol polyglyceryl-6 polyricinoleate tocopheryl acetate ammonium acryloyldimethyltaurate/vp copolymer sodium stearoyl lactylate sodium hyaluronate tetrahexyldecyl ascorbate pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate isopropyl titanium triisostearate synthetic fluorphlogopite xanthan gum silica alumina sodium dehydroacetate tin oxide disodium edta phenoxyethanol [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 7799)] [iln39833]

Other information

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

SPL UNCLASSIFIED SECTION

CLINIQUE LABS., DIST.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 40 ml Bottle Carton

C

CLINIQUE

moisture surge
CC
cream
hydrating
colour corrector
broad spectrum
SPF 30

ALL SKIN TYPES

1.4 FL.OZ.LIQ./40 ml e

INGREDIENTS AND APPEARANCE

MOISTURE SURGE CC   BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOR
octinoxate, octisalate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.08175 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0555 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.5772 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0355 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
squalane (UNII: GW89575KF9)
octyldodecyl neopentanoate (UNII: X8725R883T)
butylene glycol (UNII: 3XUS85K0RA)
propanediol (UNII: 5965N8W85T)
glyceryl monostearate (UNII: 230OU9XXE4)
docosanol (UNII: 9G1OE216XY)
peg-40 stearate (UNII: ECU18C66Q7)
aloe vera leaf (UNII: ZY81Z83H0X)
trehalose (UNII: B8WCK70T7I)
caffeine (UNII: 3G6A5W338E)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
stearic acid (UNII: 4ELV7Z65AP)
sorbitol (UNII: 506T60A25R)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
sodium stearoyl lactylate (UNII: IN99IT31LN)
hyaluronate sodium (UNII: YSE9PPT4TH)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)
xanthan gum (UNII: TTV12P4NEE)
silicon dioxide (UNII: ETJ7Z6XBU4)
aluminum oxide (UNII: LMI26O6933)
sodium dehydroacetate (UNII: 8W46YN971G)
stannic oxide (UNII: KM7N50LOS6)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-028-01	1 in 1 CARTON	01/01/2013
1		40 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	01/01/2013

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-028) , REPACK(49527-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-028)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-028)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-028) , REPACK(49527-028)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-028) , REPACK(49527-028)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-028)