LAURA GELLER SPACKLE BROAD SPECTRUM SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER- avobenzone, octinoxate, octisalate cream

LAURA GELLER spackle Broad Spectrum SPF 30 protective under make-up primer by

Drug Labeling and Warnings

LAURA GELLER spackle Broad Spectrum SPF 30 protective under make-up primer by is a Otc medication manufactured, distributed, or labeled by Laura Geller Beauty, LLC, MANA Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LAURA GELLER spackle Broad Spectrum SPF 30 protective under make-up primer

Active Ingredients

Avobenzone 3.00%
Octinoxate 7.50%
Octisalate 5.00%

Purpose

Sunscreen

USES

• 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 liberally 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.
  

INACTIVE INGREDIENTS

Water, Glycerin, Mica, Octyldodecyl Neopentanoate, Butylene Glycol, Cyclopentsiloxane, Titanium Dioxide (CI 77891), Dimethicone, Camellia Sinensis Leaf Extract, Ginkgo Biloba Leaf Extract, Aloe Barbadensis Leaf Extract, Hamamelis Virginia (Witch Hazel) Water, Centella Asiatica Extract, Lens Esculenta (Lentil) Seed Extract, Dimethiconol, Glyceryl Acrylate/Acrylic Acid Copolymer, PEG/PPG-18 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 1,2-Hexandiol, Decylene Glycol, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499).

Other Information

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

Questions or comments?

Call Laura Gellar Beauty, LLC, 1 (800) MAKE UP4

LAURA GELLER spackle Broad Spectrum SPF 30 protective under make-up primer 59ml (

51389-210-00)

INGREDIENTS AND APPEARANCE

LAURA GELLER SPACKLE BROAD SPECTRUM SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER  
avobenzone, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51389-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MICA (UNII: V8A1AW0880)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE (UNII: 92RU3N3Y1O)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GINKGO (UNII: 19FUJ2C58T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
LENTIL (UNII: 6O38V6B52O)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DECYLENE GLYCOL (UNII: S57M60MI88)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 51389-210-00	1 in 1 PACKAGE
1		59 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/14/2014

Labeler - Laura Geller Beauty, LLC (199474524)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Products, Inc.		078870292	manufacture(51389-210)