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CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 WARM HONEY

Dosage form: cream
Ingredients: OCTINOXATE 1.28g in 32g, TITANIUM DIOXIDE .96g in 32g
Labeler: ELIZABETH ARDEN, INC
NDC Code: 67938-0944

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.

Drug Facts

Active ingredients

OCTINOXATE 4.0%

TITANIUM DIOXIDE 3.0%

Purpose

Sunscreen

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 For Sunscreen Use:
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

WATER/AQUA/EAU, CYCLOPENTASILOXANE, DIMETHICONE, ISOHEXADECANE, MICA, GLYCERIN, SORBITAN ISOSTEARATE, DIMETHICONE CROSSPOLYMER, ALUMINA, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, ALUMINUM/MAGNESIUM HYDROXIDE STEARATE, ACETYL OCTAPEPTIDE-3, ALANINE, ALPINIA SPECIOSA LEAF EXTRACT, ASCORBYL PALMITATE, ASPARTIC ACID, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CHOLESTEROL DEXTRIN, DISODIUM EDTA, FRUCTOSE, GLUCOSE, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, LECITHIN, MANNITOL, PCA DIMETHICONE PHYTOSPHINGOSINE, POLYPERFLUOROETHOXYMET HOXY DIFLUOROETHYL PEG PHOSPHATE, POLYQUATERNIUM-51, RETINYL PALMITATE, SILICA SILYLATE, SODIUM CHLORIDE, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, SODIUM PCA, SORBITOL, SUCROSE, TOCOPHEROL, TREHALOSE, TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT UREA, XANTHAN GUM, ZINC STEARATE, BHT, BENZOIC ACID CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Other Information
  • Protect this product from excessive heat and direct sun

Questions or comments?
  • Call toll free 1-800 326-7337

Principal Display Panel - Carton Label

Elizabeth Arden

NEW YORK

Ceramide

Lift and Firm Makeup

Broad Spectrum Sunscreen SPF 15

NET WT. 1 OZ. 32 g

CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 WARM HONEY 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0944
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1.28 g  in 32 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE.96 g  in 32 g
Inactive Ingredients
Ingredient NameStrength
ACETYL OCTAPEPTIDE-3 
ALANINE 
ALPINIA ZERUMBET LEAF 
ALUMINUM OXIDE 
ASCORBYL PALMITATE 
ASPARTIC ACID 
BENZOIC ACID 
BUTYLATED HYDROXYTOLUENE 
BUTYLENE GLYCOL 
CAPRYLYL GLYCOL 
CERAMIDE 1 
CERAMIDE 3 
CERAMIDE 6 II 
CHLORPHENESIN 
CHOLESTEROL 
CYCLOMETHICONE 5 
ICODEXTRIN 
DIMETHICONE 
EDETATE DISODIUM 
FRUCTOSE 
DEXTROSE, UNSPECIFIED FORM 
GLYCERIN 
HEXYLENE GLYCOL 
ABELMOSCHUS MOSCHATUS SEED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
ISOHEXADECANE 
MANNITOL 
METHYLPARABEN 
MICA 
PHENOXYETHANOL 
PHYTOSPHINGOSINE 
POTASSIUM SORBATE 
PROPYLPARABEN 
VITAMIN A PALMITATE 
SODIUM CHLORIDE 
HYALURONATE SODIUM 
SODIUM LAUROYL LACTYLATE 
SODIUM PYRROLIDONE CARBOXYLATE 
SORBITAN ISOSTEARATE 
SORBITOL 
SUCROSE 
TOCOPHEROL 
TREHALOSE 
TRIFOLIUM PRATENSE FLOWER 
UREA 
WATER 
XANTHAN GUM 
ZINC STEARATE 
Packaging
#Item CodePackage Description
1NDC:67938-0944-11 JAR in 1 BOX
1NDC:67938-0944-232 g in 1 JAR
2NDC:67938-0944-325000 g in 1 PAIL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/24/2015
Labeler - ELIZABETH ARDEN, INC (849222187)
Establishment
NameAddressID/FEIOperations
KOLMAR001535103MANUFACTURE(67938-0944)

Revised: 07/2015
 
ELIZABETH ARDEN, INC

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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