COLOR CORRECTING SWIRL FOUNDATION BROAD SPECTRUM SPF 25 TAN- octocrylene avobenzone octisalate cream

color correcting swirl foundation broad spectrum SPF 25 by

Drug Labeling and Warnings

color correcting swirl foundation broad spectrum SPF 25 by is a Otc medication manufactured, distributed, or labeled by LAURA GELLER MAKE UP INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octocrylene 5%

Avobenzone 3%

Octisalate 3%

Purpose

Sunscreen

Use

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions),decreases the risk of skin cancer and early 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 generously 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
  
• Reapply at least every 2 hours.
• 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.
  

Other Information

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

Inactive Ingredients

Isostearyl Neopentanoate, Isohexadecane, C12-15 Alkyl Benzoate, Butylene Glycol Cocoate, Titanium Dioxide, Hydrogenated Castor Oil, Polymethyl Methacrylate, Cetearyl Ethylhexanoate, Mica, Silica, Ceresin, Silica Dimethyl Silylate, Ascorbyl Tetraisopalmitate, Tocopheryl Acetate, PPG-15 Stearyl Ether, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Caprylic/Capric Triglyceride, Isopropyl Myristate, Plankton Extract, Glycine Soja Oil (Glycine Soja (Soybean) Oil), Tribehenin, Retinyl Palmitate, Carthamus Tinctorius Seed Oil (Carthamus Tinctorius (Safflower) Seed Oil),Linoleic Acid, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide

MAY CONTAIN: Titanium Dioxide, Iron Oxide, Iron Oxide, Ultramarines, Yellow 5 Lake, Yellow 6 Lake

Questions?

Call Laura Geller Beauty, LLC., 1(800) MAKE UP4

Principal Display Panel

LAURA GELLER

BEAUTY INGENUITY

cc creme compact

color correcting swirl foundation

braod spectrum

SPF 25

with sponge

TAN

Net Wt. 0.37 oz/10.5 g

INGREDIENTS AND APPEARANCE

COLOR CORRECTING SWIRL FOUNDATION BROAD SPECTRUM SPF 25  TAN
octocrylene avobenzone octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51389-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ISOHEXADECANE (UNII: 918X1OUF1E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CERESIN (UNII: Q1LS2UJO3A)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TRICAPRIN (UNII: O1PB8EU98M)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SOYBEAN OIL (UNII: 241ATL177A)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SAFFLOWER OIL (UNII: 65UEH262IS)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CERAMIDE 2 (UNII: C04977SRJ5)
RAPESEED STEROL (UNII: B46B6DD20U)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51389-121-01	10.5 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/02/2013

Labeler - LAURA GELLER MAKE UP INC. (199474524)