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Laura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Bronze Radiance

Dosage form: cream
Ingredients: AVOBENZONE 20mg in 1mL, OCTINOXATE 75mg in 1mL
Labeler: Gurwitch Products, L.L.C.
NDC Code: 65342-1394

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.

Laura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Bronze Radiance

Drug Facts

Active Ingredient

Avobenzone (2.0%), Octinoxate (7.5%)

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • For sunscreen use:
  • 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

Other information

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

Inactive ingredients

water, dimethicone, cetearyl alcohol, hydrogenated polyisobutene, xylitylglucoside, PEG-40 castor oil, polyglyceryl-4 isostearate, cyclopentasiloxane, potassium cetyl phosphate, hexyl laurate, anhydroxylitol, mica, tocopheryl acetate, cetyl PEG/PPG-10/1 dimethicone, xylitol, polysorbate 60, phenoxyethanol, butylene glycol, tribhenin, sodium dehydroacetate, sodium hyaluronate, allantoin, camellia sinensis leaf extract, copper gluconate, carbomer, hydrogenated olive oil, butyrospermum parkii (shea) butter, aminomethyl propanol, tetrasodium EDTA, magnesium aluminum silicate, sodium ascorbate, dipotassium glcyrrhizate, may contain: titanium dioxide, iron oixides, copper powder.

Questions or comments?

Call 1-888-637-2437, M - F 9am - 5 pm CST.

Product Labels

LAURA MERCIER TINTED MOISTURIZER - ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN - BRONZE RADIANCE 
avobenzone, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-1394
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE20 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
XYLITYLGLUCOSIDE 
PEG-40 CASTOR OIL 
POLYGLYCERYL-4 ISOSTEARATE 
CYCLOMETHICONE 5 
POTASSIUM CETYL PHOSPHATE 
HEXYL LAURATE 
ANHYDROXYLITOL 
MICA 
.ALPHA.-TOCOPHEROL ACETATE 
XYLITOL 
POLYSORBATE 60 
PHENOXYETHANOL 
BUTYLENE GLYCOL 
SODIUM DEHYDROACETATE 
HYALURONATE SODIUM 
ALLANTOIN 
GREEN TEA LEAF 
HYDROGENATED OLIVE OIL 
SHEANUT OIL 
AMINOMETHYLPROPANOL 
EDETATE SODIUM 
MAGNESIUM ALUMINUM SILICATE 
SODIUM ASCORBATE 
TITANIUM DIOXIDE 
COPPER 
Packaging
#Item CodePackage Description
1NDC:65342-1394-050 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/29/2010
Labeler - Gurwitch Products, L.L.C. (884875246)
Establishment
NameAddressID/FEIOperations
Atlantis Laboratories, Inc.194673984manufacture(65342-1394)
Establishment
NameAddressID/FEIOperations
Beauty Manufacturing Solutions Corp.783200723pack(65342-1394)

Revised: 07/2015
 
Gurwitch Products, L.L.C.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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