LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN LIGHTWEIGHT FLAWLESS COVERAGE CAMEO- octinoxate, octisalate cream 
Gurwitch Products, LLC

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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laura mercier tinted moisturizer oil free Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage CAMEO

laura mercier tinted moisturizer oil free Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage CAMEO


Active Ingredients

Octinoxate 5.5%

Octisalate 3.0%

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 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 values 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, Disiloxane, PEG-30 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Ethylhexyl Palmitate, Glycerin, Isohexadecane, Cyclopentasiloxane, Phenoxyethanol, Boron Nitride, Jojoba Esters, Magnesium Stearate, Sodium Dehydroacetate, Squalane, Methicone, Disodium EDTA, Methylparaben, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Propylparaben, Lauryl PCA, Tocopheryl Acetate, PPG-15 Stearyl Ether, Isopropyl Titanium Triisostearate, Dipotassium Glycyrrhizate.

May Contain: Titanium Dioxide, Iron Oxides.

Questions or comments?

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

laura mercier tinted moisturizer oil free Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage CAMEO 50ml (65342-0001-0)


InnerPackage

OuterPackage

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN LIGHTWEIGHT FLAWLESS COVERAGE CAMEO 
octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
SIMMONDSIA CHINENSIS WHOLE (UNII: DFM16KFA82)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PCA (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65342-0001-050 mL in 1 TUBE; Type 0: Not a Combination Product02/06/201312/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/06/201312/31/2022
Labeler - Gurwitch Products, LLC (884875246)
Establishment
NameAddressID/FEIBusiness Operations
Gotha Cosmetics SRL378071679manufacture(65342-0001)

Revised: 2/2021
 
Gurwitch Products, LLC