CERAMIDE LIFT AND FIRM EYE SPF 15- oxybenzone, octinoxate emulsion

CERAMIDE LIFT and FIRM EYE SPF 15 by

Drug Labeling and Warnings

CERAMIDE LIFT and FIRM EYE SPF 15 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 PURPOSE

Active Ingredients Purpose
OCTINOXATE 4.1% ....... Sunscreen
OXYBENZONE 1.4% ....... Sunscreen

OTHER INGREDIENTS

Other Ingredients: Aqua/Water/Eau, Dimethicone, Cetyl Ricinoleate, Cetearyl Alcohol,
Glycerin, Synthetic Beeswax, Butylene Glycol, Pentylene Glycol, Stearyl Heptanoate,
Hydrogenated Polyisobutene, Myristyl Myristate, Isononyl Isononanoate, Cetearyl Dimethicone
Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cera Carnauba/Copernicia
Cerifera (Carnauba) Wax/Cire de carnauba, PPG-2 Isoceteth-20 Acetate, Acetyl Octapeptide-3,
Ascorbyl Glucoside, Ascorbyl Palmitate, Bis-PEG-12 Dimethicone, Camellia Sinensis Leaf
Extract, Caprylyl Glycol, Cera Alba/Beeswax/Cire D'abeille, Ceramide AP, Ceramide EOP,
Ceramide NP, Ceteth-20, Cholesterol, Cyclopentasiloxane, Dipeptide-2, Disodium EDTA,
Glycine Soja (Soybean) Seed Extract, Hexylene Glycol, Hibiscus Abelmoschus Seed Extract,
Leuconostoc/Radish Root Ferment Filtrate, Myristyl Laurate, Palmitoyl Tetrapeptide-7, PEG-100
Stearate, PEG-20, Phospholipids, Phytosphingosine, PVP, Pyrus Malus (Apple) Fruit Extract,
Silica, Sodium Hydroxide, Sodium Lauroyl Lactylate, Sorbitan Tristearate, Steareth-100,
Steareth-20, Tocopheryl Acetate, Triethanolamine, VP/Eicosene Copolymer, Xanthan Gum,
BHT, Hesperidin Methyl Chalcone, Chlorhexidine Digluconate, Phenoxyethanol, Potassium
Sorbate.

USES

Uses

- Helps prevent sunburn

WARNINGS

Warnings
Skin Cancer/Skin Aging Alert:
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

- 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
- Children under 6 months: Ask a doctor.

DOSAGE & ADMINISTRATION

As needed

INDICATIONS & USAGE

• Helps prevent sunburn

PURPOSE

Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

DRUG FACTS BOX

CARTON ART

INGREDIENTS AND APPEARANCE

CERAMIDE LIFT AND FIRM EYE SPF 15 
oxybenzone, octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-667
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.1 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
SOYBEAN (UNII: L7HT8F1ZOD)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)
BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
STEARETH-20 (UNII: L0Q8IK9E08)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARETH-100 (UNII: 4OH5W9UM87)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
PEG-100 STEARATE (UNII: YD01N1999R)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
CETYL RICINOLEATE (UNII: 1P677500YD)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
CETETH-20 (UNII: I835H2IHHX)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
APPLE (UNII: B423VGH5S9)
CHOLESTEROL (UNII: 97C5T2UQ7J)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-667-61	14.4 g in 1 JAR; Type 0: Not a Combination Product	04/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/19/2019

Labeler - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC dba Voyant Beauty		032565959	manufacture(10967-667)