FLAWLESS FUTURE MOISTURE- octinoxate, octisalate, oxybenzone and avobenzone cream

FLAWLESS FUTURE MOISTURE by

Drug Labeling and Warnings

FLAWLESS FUTURE MOISTURE by is a Otc medication manufactured, distributed, or labeled by ELIZABETH ARDEN, INC, ENGLEWOOD LAB. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OCTINOXATE 7.14 %

OCTISALATE 4.75 %

OXYBENZONE 4.00 %

AVOBENZONE 3.00 %

Purpose

Sunscreen

Sunscreen

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, GLYCERIN, DIMETHICONE, ARGANIA SPINOSA KERNEL OIL, C12-15 ALKYL BENZOATE, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOPENTASILOXANE, CETYL ALCOHOL, STEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, ADENOSINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BISABOLOU CAPRYLYL GLYCOL, CARAMEL, CARBOMER, CERAMIDE1, CERAMIDE3, CERAMIDE6 II, CHOLESTEROL, DIPOTASSIUM GLYCYRRHIZATE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, FUCOSE, GLUCOSE, GLUCURONIC ACID, HYDROLYZED SOY PROTEIN, HYDROLYZED YEAST PROTEIN, JOJOBA ESTERS, KEFIRAN, PANTHENOL, PARFUM/FRAGRANCE, PHYTOSPHINGOSINE, PROPYLENE GLYCOL, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, TOCOPHEROL, XANTHAN GUM, BHT, ALPHA-ISOMETHYLIONONE, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, GERANIOL, HEXYL CINNAMAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, SODIUM BENZOATE, RED 40 (Cl 16035).

Other Information

• Protect this product from excessive heat and direct sun

Questions or comments?

• Call toll free 1-800 326-7337

Principal Display Panel - Box Label

Elizabeth Arden
NEW YORK

FLAWLESS FUTURE

Powered by Ceramide™

Moisture Cream
Broad Spectrum Sunscreen SPF 30

NET WT. 1.7 OZ. 50 g

INGREDIENTS AND APPEARANCE

FLAWLESS FUTURE MOISTURE 
octinoxate, octisalate, oxybenzone and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-2050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.57 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.375 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ARGAN OIL (UNII: 4V59G5UW9X)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PANTHENOL (UNII: WV9CM0O67Z)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
ADENOSINE (UNII: K72T3FS567)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
CARAMEL (UNII: T9D99G2B1R)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
CERAMIDE 3 (UNII: 4370DF050B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DEXTROSE (UNII: IY9XDZ35W2)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FUCOSE (UNII: 28RYY2IV3F)
GLUCURONIC ACID (UNII: 8A5D83Q4RW)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SOY PROTEIN (UNII: R44IWB3RN5)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
TOCOPHEROL (UNII: R0ZB2556P8)
SOLVENT RED 4 (UNII: EVE9WNU99R)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-2050-1	1 in 1 BOX
1	NDC: 67938-2050-2	50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/07/2014

Labeler - ELIZABETH ARDEN, INC (849222187)

Establishment
Name	Address	ID/FEI	Business Operations
ENGLEWOOD LAB		172198223	MANUFACTURE(67938-2050)