FLAWLESS FUTURE SPF 30- octinoxate, octisalate, oxybenzone, avaobenzone emulsion

FLAWLESS FUTURE SPF 30 by

Drug Labeling and Warnings

FLAWLESS FUTURE SPF 30 by is a Otc medication manufactured, distributed, or labeled by REVLON, Englewood Lab. INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTINOXATE 7.14%

OCTISALATE 4.75%

OXYBENZONE 4.00%

AVOBENZONE 3.00%

OTHER 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, BISABOLOL, CAPRYLYL GLYCOL, CARAMEL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 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-ISOMETHYL IONONE, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, GERANIOL, HEXYL CINNAMAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, SODIUM BENZOATE, RED 40 (CI 16035)

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.

CARTON ART

INGREDIENTS AND APPEARANCE

FLAWLESS FUTURE SPF 30 
octinoxate, octisalate, oxybenzone, avaobenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-683
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.14 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.75 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
KEFIRAN (UNII: 8L821V6V99)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARAMEL (UNII: T9D99G2B1R)
CHOLESTEROL (UNII: 97C5T2UQ7J)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ARGAN OIL (UNII: 4V59G5UW9X)
PEG-100 STEARATE (UNII: YD01N1999R)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
SHEA BUTTER (UNII: K49155WL9Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 6 II (UNII: F1X8L2B00J)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
FUCOSE (UNII: 28RYY2IV3F)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ADENOSINE (UNII: K72T3FS567)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
LEVOMENOL (UNII: 24WE03BX2T)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CERAMIDE 3 (UNII: 4370DF050B)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-683-17	50 g in 1 JAR; Type 0: Not a Combination Product	02/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/06/2017

Labeler - REVLON (788820165)

Registrant - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab. INC.		080987545	manufacture(10967-683)