LORAC FOUNDATION DEEP SPF20- octinoxate, octisalate and avobenzone emulsion 
Lorac Cosmetics, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Ocitsalate 5.0%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (See Directions), decreases the rist of skin cancer and early skin-aging cause by the sun.

Warnings

For exteral use Only

  • Keep away  from the eye area
  • Stop use if irritation occurs
  • If irritation persists consult a health practitioner

Keep out of reach of children

Do not use on damaged or broken skin

Directions

Apply 15 minutes prior to sun exposure and reapply as needed

  • Spending time in the sun increases your risk of skin cancer and early skin aging
  • To decrease this risk, regularly use a sunscreen with Broad Spectrum value at 15 or higher and other sun protection measures including
  • Limit time in the sun, expecially from 10 a.m. to 2 p.m.
  • Wear long-sleeved shirts, hats, pants 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

WATER, CYCLOPENTASILOXANE, POLYMETHYLSILSESUIOXANE, ETHYLHEXYL PALMITATE, GLYCERIN, NEOPENTYL GLYCOL DIHEPTANOATE, TRIMETHYLSILOXYSILICATE,  HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, QUATERNIUM-90 BENTONITE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, POTASSIUM SORBATE, PHENYL TRIMETHICONE, TOCOPHERYL ACETATE, POLYGLYCERYL-3 BEESWAX,  MICROCRYSTALINE WAX, PROPYLENE CARBONATE, RETINYL PALMITATE, POLYHYDROXYSTEARIC ACID, LECITHIN, ISOPROPYL MYRISTATE, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, PHENOXYETHANOL, CAPRYLYL GLYCOL, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT, MAY CONTAIN : TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI77492, CI 77491, CI 77499), MICA (CI 77019).

Questions or Comments

Call Customer Care 1-800-845-0705

Mon-Fri between 8 am - 4pm PST

LoracSPF20Ctn

LORAC FOUNDATION DEEP  SPF20
octinoxate, octisalate, avobenzone emulsion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52773-244
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5.0 g  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) 
ETHYLHEXYL PALMITATE 
GLYCERIN 
NEOPENTYL GLYCOL DIHEPTANOATE 
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) 
HEXAMETHYLENE DIISOCYANATE 
BENTOQUATAM 
MAGNESIUM SULFATE 
SODIUM CHLORIDE 
SODIUM BENZOATE 
POTASSIUM SORBATE 
PHENYL TRIMETHICONE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
MICROCRYSTALLINE WAX 
PROPYLENE CARBONATE 
VITAMIN A PALMITATE 
POLYHYDROXYSTEARIC ACID (2300 MW) 
EGG PHOSPHOLIPIDS 
ISOPROPYL MYRISTATE 
ISOSTEARIC ACID 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) 
POLYGLYCERYL-3 DIISOSTEARATE 
POLYGLYCERYL-3 RICINOLEATE 
OLEA EUROPAEA LEAF 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
CHLORPHENESIN 
TRIETHOXYCAPRYLYLSILANE 
CARICA PAPAYA WHOLE 
CITRUS MEDICA FRUIT 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52773-244-021 in 1 CARTON
1NDC:52773-244-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2013
Labeler - Lorac Cosmetics, Inc. (940915473)
Registrant - Northwest Cosmetic Laboratories (929572014)
Establishment
NameAddressID/FEIBusiness Operations
Northwest Cosmetic Laboratories929572014manufacture(52773-244)

Revised: 9/2013
 
Lorac Cosmetics, Inc.