CERAMIDE LIFT AND FIRM- octinoxate, oxybenzone, avobenzone, octisalate, octocrylene emulsion

CERAMIDE LIFT and FIRM by

Drug Labeling and Warnings

CERAMIDE LIFT and FIRM by is a Otc medication manufactured, distributed, or labeled by REVLON, Cosmetic Essence, LLC dba Voyant Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTINOXATE 7.5%.................................. Sunscreen
OXYBENZONE 5.0%................................ Sunscreen
OCTISALATE 5.0% .................................. Sunscreen
OCTOCRYLENE 2.2% ............................. Sunscreen
AVOBENZONE 2.0%................................ 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

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

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.

OTHER INGREDIENTS

WATER/AQUA/EAU, DIMETHICONE, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, ISOSTEARYL NEOPENTANOATE, CYCLOPENTASILOXANE, THEOBROMA CACAO (COCOA) SEED BUTTER, PPG-2 ISOCETETH-20 ACETATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERIN, ACETYL OCTAPEPTIDE-3, ACRYLAMIDE/SODIUM ACRYLATE COPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALPINIA SPECIOSA LEAF EXTRACT, ASCORBYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CETEARYL ALCOHOL, CETEARYL DIMETHICONE CROSSPOLYMER, CHOLESTEROL, CYCLOHEXASILOXANE, DIMETHICONE CROSSPOLYMER, DIMETHICONOL, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, HYDROGENATED LECITHIN, HYDROGENATED PHOSPHATIDYLCHOLINE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, LECITHIN, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, PARFUM/FRAGRANCE, PEG-8, PHENYL TRIMETHICONE, PHOSPHOLIPIDS, PHYTOSPHINGOSINE, POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE, POLYQUATERNIUM-51, POLYSORBATE 60, PROPYLENE GLYCOL, RETINYL LINOLEATE, RETINYL PALMITATE, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM LAUROYL LACTYLATE, SODIUM PCA, SUCROSE, TOCOPHERYL ACETATE, TREHALOSE, TRIDECETH-6, TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT, UREA, XANTHAN GUM, BHT, ALPHA-ISOMETHYL IONONE, BUTYLPHENYL METHYLPROPIONAL, CITRAL, GERANIOL, LIMONENE, LINALOOL, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, RED 4 (CI 14700), YELLOW 6 (CI 15985).

DOSAGE & ADMINISTRATION

As needed

WARNINGS

Warnings

• For external use only
• Do not use on damage 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.

INDICATIONS & USAGE

• Helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

PURPOSE

Sunscreen

DRUG FACTS BOX

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAMIDE LIFT AND FIRM 
octinoxate, oxybenzone, avobenzone, octisalate, octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-666
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
ACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE 3 (UNII: 4370DF050B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
COCOA BUTTER (UNII: 512OYT1CRR)
PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
CITRAL (UNII: T7EU0O9VPP)
CERAMIDE 1 (UNII: 5THT33P7X7)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ISOHEXADECANE (UNII: 918X1OUF1E)
UREA (UNII: 8W8T17847W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
RETINYL LINOLEATE (UNII: 61911N8D6W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1) (UNII: X8Q92E1CPM)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GERANIOL (UNII: L837108USY)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIDECETH-6 (UNII: 3T5PCR2H0C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-666-17	49 g in 1 JAR; Type 0: Not a Combination Product	10/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/24/2016

Labeler - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC dba Voyant Beauty		032565959	manufacture(10967-666)