CLINIQUE BROAD SPECTRUM SPF 30 SUNSCREEN BODY MIST- avobenzone, homosalate, and octisalate liquid

Clinique Broad Spectrum SPF 30 Sunscreen Body Mist by

Drug Labeling and Warnings

Clinique Broad Spectrum SPF 30 Sunscreen Body Mist 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

Avobenzone 3.0%
Homosalate 10.0%
Octisalate 4.5%

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

• spray generously and spread evenly by hand 15 minutes before sun exposure
• hold 4–6 inches from the body when spraying
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• do not apply in windy conditions
• use in a well-ventilated area
• 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

alcohol denat. octyldodecyl neopentanoate butyloctyl salicylate polyester-8 acrylates/octylacrylamide copolymer ethylhexyl methoxycrylene dimethicone trimethylsiloxysilicate tocopheryl acetate ethylcellulose [iln42861]

Other information

• protect the product in this container from excessive heat and direct sun
• store in a cool, dry place

PRINCIPAL DISPLAY PANEL - 144 ml Bottle Carton

CLINIQUE

broad
spectrum
SPF 30
sunscreen

UVA UVB
advanced
protection

virtu-oil
body mist

4.9 FL.OZ.
144 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE BROAD SPECTRUM SPF 30 SUNSCREEN BODY MIST 
avobenzone, homosalate, and octisalate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-059
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0261 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.087 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0392 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
octyldodecyl neopentanoate (UNII: X8725R883T)
butyloctyl salicylate (UNII: 2EH13UN8D3)
polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) (UNII: T9296U138P)
ethylhexyl methoxycrylene (UNII: S3KFG6Q5X8)
dimethicone (UNII: 92RU3N3Y1O)
ethylcellulose, unspecified (UNII: 7Z8S9VYZ4B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-059-01	1 in 1 CARTON	06/01/2017
1		144 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	06/01/2017

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-059) , REPACK(49527-059)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-059)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-059)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-059)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-059)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-059) , REPACK(49527-059)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-059) , REPACK(49527-059)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-059)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-059)