CAUDALIE RESVERATROL FACE LIFTING MOISTURIZER BROAD SPECTRUM SPF 20- avobenzone, octinoxate, octisalate, octocrylene cream 
Caudalie USA 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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Caudalie Resveratrol Face Lifting Moisturizer Broad Spectrum SPF 20

Drug Facts

Active ingredients

Avobenzone  3.00%
Octinoxate     4.00%
Octisalate      5.00%
Octocrylene    8.00%

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

Directions

  • Apply generously 15 minutes before sun exposure.
  • Apply to all skin exposed to the sun.
  • Children under 6 months of age: ask a doctor.
  • 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.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.

Other information

  • Protect the product in this container from excessive heat and direct sun.
  • You may report a serious adverse event from use of this product to Caudalie USA New York, 70 West 36th Street, 13th Floor, NYC, NY  10018.

Inactive ingredients

AQUA (WATER), HEPTYL UNDECYLENATE, DIMETHICONE, DICAPRYLYL CARBONATE, METHYL METHACRYLATE CROSSPOLYMER, BUTYLENE GLYCOL, SQUALANE, GLYCERYL STEARATE CITRATE, CI 77891 (TITANIUM DIOXIDE), GLYCERIN, POTASSIUM CETYL PHOSPHATE, POLYGLYCERYL-3 STEARATE, SILICA, CI 77019 (MICA), HYDROGENATED LECITHIN, TOCOPHERYL ACETATE, BENZYL ALCOHOL, PALMITOYL GRAPEVINE SHOOT EXTRACT, CAPRYLYL GLYCOL, PARFUM (FRAGRANCE), XANTHAN GUM, SODIUM POLYACRYLATE, SORBITAN LAURATE, HYDROLYZED HYALURONIC ACID, HYDROXYETHYLCELLULOSE, DEHYDROACETIC ACID, ACETYL DIPEPTIDE-1 CETYL ESTER, HYALURONIC ACID, SODIUM PHYTATE, CITRIC ACID, TIN OXIDE, TOCOPHEROL, LINALOOL, LIMONENE, COUMARIN, BUTYLPHENYL METHYLPROPIONAL.

Product Label

DrugFactscarton

CAUDALIE RESVERATROL FACE LIFTING MOISTURIZER BROAD SPECTRUM SPF 20 
avobenzone, octinoxate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76296-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SQUALANE (UNII: GW89575KF9)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)  
HYALURONIC ACID (UNII: S270N0TRQY)  
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
COUMARIN (UNII: A4VZ22K1WT)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76296-014-401 in 1 CARTON07/29/201502/28/2018
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/29/201502/28/2018
Labeler - Caudalie USA Inc. (100064349)

Revised: 2/2018
 
Caudalie USA Inc.