CERAMIDE MAKEUP SPF 15- octinoxate, titanium dioxide cream

CERAMIDE MAKEUP SPF 15 by

Drug Labeling and Warnings

CERAMIDE MAKEUP SPF 15 by is a Otc medication manufactured, distributed, or labeled by REVLON, Revlon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients Purpose

OCTINOXATE 4.0%.............. Sunscreen
TITANIUM DIOXIDE 3.0% .... Sunscreen

Inactive Ingredients

Inactive Ingredients
WATER/AQUA/EAU, CYCLOPENTASILOXANE, DIMETHICONE, ISOHEXADECANE, MICA, GLYCERIN, SORBITAN ISOSTEARATE, DIMETHICONE CROSSPOLYMER, ALUMINA, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, ALUMINUM/MAGNESIUM HYDROXIDE STEARATE, ACETYL OCTAPEPTIDE-3, ALANINE, ALPINIA SPECIOSA LEAF EXTRACT, ASCORBYL PALMITATE, ASPARTIC ACID, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CHOLESTEROL, DEXTRIN, DISODIUM EDTA, FRUCTOSE, GLUCOSE, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, LECITHIN, MANNITOL, PCA DIMETHICONE, PHYTOSPHINGOSINE, POLYPERFLUOROETHOXYMETHOXY DIFLUOROETHYL PEG PHOSPHATE, POLYQUATERNIUM-51, RETINYL PALMITATE, SILICA SILYLATE, SODIUM CHLORIDE, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, SODIUM PCA, SORBITOL, SUCROSE, TOCOPHEROL, TREHALOSE, TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT, UREA, XANTHAN GUM, ZINC STEARATE, BHT, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Uses

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.

DOSAGE & ADMINISTRATION

As needed

INDICATIONS & USAGE

Helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed seek medical help or contact a Poison Control Center right away.

PURPOSE

Sunscreen

carton art

INGREDIENTS AND APPEARANCE

CERAMIDE MAKEUP SPF 15 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-668
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
TREHALOSE (UNII: B8WCK70T7I)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BENZOIC ACID (UNII: 8SKN0B0MIM)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FRUCTOSE (UNII: 6YSS42VSEV)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALANINE (UNII: OF5P57N2ZX)
ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX)
ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
ACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)
MANNITOL (UNII: 3OWL53L36A)
ASPARTIC ACID (UNII: 30KYC7MIAI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CERAMIDE 1 (UNII: 5THT33P7X7)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
UREA (UNII: 8W8T17847W)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
MICA (UNII: V8A1AW0880)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-668-01	32 g in 1 JAR; Type 0: Not a Combination Product	11/11/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/11/2015

Labeler - REVLON (788820165)

Registrant - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Revlon		809725570	manufacture(10967-668)