ACNE BB BROAD SPECTRUM SPF 40- octinoxate, octisalate, and titanium dioxide cream

ACNE BB BROAD SPECTRUM SPF 40 by

Drug Labeling and Warnings

ACNE BB BROAD SPECTRUM SPF 40 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., JO COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 2%
Titanium Dioxide 1.6%

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 ‘methyl trimethicone ‘alcohol‘ ethylhexyl palmitate ‘peg-9 polydimethylsiloxyethyl dimethicone propanediol‘‘ glycerin ‘glyceryl caprylate‘ peg-3 dimethicone‘ dimethicone ‘tocopheryl acetate ‘lecithin‘ triethoxycaprylylsilane‘ stearyl glycyrrhetinate‘ sorbitan sesquiisostearate‘ sodium hyaluronate‘ pyridoxine hcl ‘stearic acid‘ hesperidin methyl chalcone‘ palmitoyl tetrapeptide-7‘ sodium chloride‘ aluminum hydroxide ‘steareth-20‘ dipeptide-2 ‘silica ‘sodium citrate ‘phenoxyethanol‘ [+/- mica ‘iron oxides (ci 77491) ‘iron oxides (ci 77492) ‘iron oxides (ci 77499) ‘titanium dioxide (ci 77891)] [iln41343]

Other information

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

acne

C
CLINIQUE

acne solutions
BB
cream
broad spectrum SPF 40

COMBINATION OILY TO OILY

1 FL.OZ.LIQ./30 ml e

INGREDIENTS AND APPEARANCE

ACNE BB BROAD SPECTRUM SPF 40 
octinoxate, octisalate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-044
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 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0218 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01744 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
STEARIC ACID (UNII: 4ELV7Z65AP)
HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARETH-20 (UNII: L0Q8IK9E08)
VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 49527-044-01	1 in 1 CARTON	11/01/2014
1		30 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	11/01/2014

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-044) , REPACK(49527-044)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-044)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-044)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-044)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-044)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-044) , REPACK(49527-044)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-044) , REPACK(49527-044)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-044)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-044)

Establishment
Name	Address	ID/FEI	Business Operations
JO COSMETICS		691485222	MANUFACTURE(49527-044)