CLINIQUE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN FOR BODY- titanium dioxide and zinc oxide liquid

CLINIQUE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN FOR BODY by

Drug Labeling and Warnings

CLINIQUE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN FOR BODY 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

Titanium Dioxide 3.2%
Zinc Oxide 2.0%

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:
  • 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 caprylyl methicone butyloctyl salicylate isononyl isononanoate neopentyl glycol diheptanoate dimethicone/peg-10/15 crosspolymer butylene glycol diethylhexyl succinate dipentaerythrityl tri-polyhydroxystearate c12-15 alkyl benzoate lauryl peg-9 polydimethylsiloxyethyl dimethicone trimethylsiloxysilicate hydroxyapatite cetyl peg/ppg-10/1 dimethicone methyl trimethicone hydrolyzed wheat protein/pvp crosspolymer caprylyl glycol dimethicone silylate quaternium-90 bentonite sodium chloride triethoxycaprylylsilane dimethicone crosspolymer-3 isostearic acid silica polyhydroxystearic acid propylene carbonate sodium citrate disodium edta phenoxyethanol iron oxides (ci 77492) iron oxides (ci 77491) [iln41696]

Other information

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

PRINCIPAL DISPLAY PANEL - 125 ml Bottle Carton

CLINIQUE

broad
spectrum
SPF 30

UVA UVB
invisible shield
technology

mineral
sunscreen lotion
for body
sensitive skin formula

4.2 FL. OZ.
125 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN FOR BODY 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	0.032 g  in 1 mL
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-058-01	1 in 1 CARTON	06/01/2016
1		125 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	06/01/2016

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-058) , REPACK(49527-058)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-058)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-058)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-058)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-058)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-058) , REPACK(49527-058)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-058) , REPACK(49527-058)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-058)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-058)