COMPACT FOUNDATION SPF 50 COLOR 01- octinoxate, octisalate, and titanium dioxide cream

Compact Foundation SPF 50 by

Drug Labeling and Warnings

Compact Foundation SPF 50 by is a Otc medication manufactured, distributed, or labeled by ORLANE, Inc., Orlane, Orleans. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients		Purpose
Octinoxate	2%	Sunscreen
Octisalate	5%	Sunscreen
Titanium dioxide	19%	Sunscreen

Uses

• Helps Prevent Sunburn.
• If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and e arly skin aging caused by the sun.

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

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 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 aging. To decrease this risk, regularly use a sunscreen with 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.

Other information

• Protect the product in this container from excessive heat and sun.

Inactive ingredients

C12-15 ALKYL BENZOATE, ISOSTEARYL NEOPENTANOATE, TALC, OCTYLDODECANOL, HYDROGENATED CASTOR OIL, POLYMETHYL METACRYLATE, TRIMETHYLSILOXYPHENYL DIMETHICONE, HYDROGENATED CASTOR OIL HYDROXYSTEARATE, ISOHEXADECANE, KAOLIN, CERESIN, POLYGLYCERYL-4 ISOSTEARATE, STEARIC ACID, TOCOPHERYL ACETATE, FRAGRANCE, SILICA DIMETHYL SILYLATE, SILICA, OCTYLDODECYL PCA, ETHYLHEXYL PALMITATE, PPG-15 STEARYL ETHER, RED 7 LAKE, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, SODIUM HYALURONATE, IRON OXIDES.

PRINCIPAL DISPLAY PANEL - 9 mL Case Carton

COMPACT FOUNDATION SPF 50
SUN GLOW
SUNSCREEN

Just like the sun's touch, Compact
Foundation Ensoleillé enhances the
brightness of your skin, guaranteeing
a natural opaque hue and efficiently
protecting your skin from UV rays.
Apply with a sponge. Keep out of eyes.

RÉF. 912.71
MADE IN ITALY
45100 ORLÉANS
ORLANE 75008 PARIS
Distr. ORLANE 300 Kennedy Drive
08872 Sayreville, N.J.

INGREDIENTS AND APPEARANCE

COMPACT FOUNDATION SPF 50   COLOR 01
octinoxate, octisalate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65371-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	25 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	62.5 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	238.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
OCTYLDODECANOL (UNII: 461N1O614Y)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ISOHEXADECANE (UNII: 918X1OUF1E)
KAOLIN (UNII: 24H4NWX5CO)
CERESIN (UNII: Q1LS2UJO3A)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
D&C RED NO. 6 (UNII: 481744AI4O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65371-051-01	1 in 1 CARTON
1		9 mL in 1 CASE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/01/2015

Labeler - ORLANE, Inc. (131360992)

Establishment
Name	Address	ID/FEI	Business Operations
Orlane, Orleans		578687469	MANUFACTURE(65371-051)