ADVANCED CERAMIDE LIFT AND FIRM DAY CREAM BROAD SPECTRUM SUNSCREEN SPF 15- octisalate, octocrylene, avobenzone, homosalate emulsion

Advanced Ceramide Lift and Firm Day Cream by

Drug Labeling and Warnings

Advanced Ceramide Lift and Firm Day Cream by is a Otc medication manufactured, distributed, or labeled by REVLON, REVLON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

AVOBENZONE 3.00%

HOMOSALATE 10.0%

OCTISALATE 5.0%

OCTOCRYLENE 8.0%

OTHER INGREDIENTS

WATER/AQUA/EAU, GLYCERIN, HEXYLENE GLYCOL, DIMETHICONE, C14-22 ALCOHOLS, PEG-100 STEARATE, GLYCERYL STEARATE, STYRENE/ACRYLATES COPOLYMER, ACRYLATES/DIMETHICONE COPOLYMER, POLYMETHYLSILSESQUIXANE, ACETYL TETRAPEPTIDE-11, ACETYL TETRAPEPTIDE-9, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMMONIUM HYDROXIDE, BUTYLENE GLYCOL, C12-20 ALKYL GLUCOSIDE, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE AP, CERAMIDE EOP, CERAMIDE NP, CHOLESTEROL, DIMETHYL ISOSORBIDE, DISODIUM EDTA, ETHLYHEXYL PALMITATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL, TAURATE COPOLYMER, ISOHEXADECANE, LEONTOPODIUM ALPINUM CALLUS CULTURE EXTRACT, MARIS SAL/SEA SALT/SEL MARIN, PHYTOSPHINGOSINE, POLYSORBATE 20, POLYSORBATE 60, SILICA DIMETHYL SILYLATE, SODIUM CARRAGEENAN, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, TOCOPHERYL ACETATE, TROMETHAMINE, XANTHAM GUM, FRAGRANCE, CHLORPHENESIN, PHENOXYETHANOL.

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

• Apply liberally 15 minutes before sun exposure
• Reapply:

- at least every 2 hours

• 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

• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor.

CARTON ART

INGREDIENTS AND APPEARANCE

ADVANCED CERAMIDE LIFT AND FIRM DAY CREAM  BROAD SPECTRUM SUNSCREEN SPF 15
octisalate, octocrylene, avobenzone, homosalate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-689
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)
LEONTOPODIUM NIVALE SUBSP. ALPINUM WHOLE (UNII: 99S85B4VEB)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ACETYL TETRAPEPTIDE-11 (UNII: 0R3VC3BV8I)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERAMIDE NP (UNII: 4370DF050B)
TROMETHAMINE (UNII: 023C2WHX2V)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHOLESTEROL (UNII: 97C5T2UQ7J)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CHLORPHENESIN (UNII: I670DAL4SZ)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CERAMIDE AP (UNII: F1X8L2B00J)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ISOHEXADECANE (UNII: 918X1OUF1E)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CERAMIDE 1 (UNII: 5THT33P7X7)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARRAGEENAN SODIUM (UNII: 7CY8BVL34N)
SEA SALT (UNII: 87GE52P74G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-689-61	15 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2021
2	NDC: 10967-689-64	5 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2021
3	NDC: 10967-689-17	50 g in 1 JAR; Type 0: Not a Combination Product	08/01/2021
4	NDC: 10967-689-60	2 g in 1 PACKET; Type 0: Not a Combination Product	08/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2021

Labeler - REVLON (788820165)

Registrant - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
REVLON, INC.		809725570	manufacture(10967-689)