CERAMIDE PREMIERE BROAD SPECTRUM SPF 30- octinoxate, octisalate, oxybenzone, octocrylene, avobenzone emulsion

CERAMIDE PREMIERE BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

CERAMIDE PREMIERE BROAD SPECTRUM 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 Purpose

Active Ingredients Purpose
OCTINOXATE 7.5% ....... Sunscreen
OCTISALATE 5.0%........ Sunscreen
OXYBENZONE 4.0%........ Sunscreen
OCTOCRYLENE 3.0%. ...... Sunscreen
AVOBENZONE 2.0%....... Sunscreen

Inactive Ingredients

WATER/AQUA/EAU, DIMETHICONE, GLYCERIN, HYDROGENATED POLYISOBUTENE, PETROLATUM, GLYCERYL STEARATE, BUTYLENE GLYCOL, BUTYLOCTYL SALICYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, PEG-100 STEARATE, BUTYROSPERMUM PARKII (SHEA BUTTER), HYDROGENATED LECITHIN, DIMETHYL CAPRAMIDE, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, FUCUS SERRATUS EXTRACT, YEAST EXTRACT/FAEX/EXTRAIT DE LEVURE, RETINYL LINOLEATE, TOCOPHERYL ACETATE, CETEARYL DIMETHICONE CROSSPOLYMER, PEG-40 HYDROGENATED CASTOR OIL, SOY AMINO ACIDS, 3-AMINOPROPANE SULFONIC ACID, CALCIUM HYDROXYMETHIONINE, HYDROLYZED SOY PROTEIN, METHYL METHACRYLATE CROSSPOLYMER, PHYTOSPHINGOSINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, CHOLESTEROL, SODIUM LAUROYL LACTYLATE, PEG-8 LAURATE, POLYSORBATE 20, SODIUM DODECYLBENZENESULFONATE, STYRENE/ACRYLATES COPOLYMER, BEHENYL ALCOHOL, PENTYLENE GLYCOL, CARBOMER, HYDROXYETHYLCELLULOSE, POLYETHYLENE, XANTHAN GUM, EDTA, SODIUM HYDROXIDE, BHT, DISODIUM EDTA, MICA, TIN OXIDE, AMINOPROPYL DIMETHICONE, FRAGRANCE/PARFUM, ALPHA-ISOMETHYL IONONE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, HYDROXYCITRONELLAL, ETHYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, SODIUM BENZOATE, TITANIUM DIOXIDE (CI 77891).

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

- 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.

Artwork

INGREDIENTS AND APPEARANCE

CERAMIDE PREMIERE BROAD SPECTRUM SPF 30 
octinoxate, octisalate, oxybenzone, octocrylene, avobenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-669
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
CHOLESTEROL (UNII: 97C5T2UQ7J)
GLYCERIN (UNII: PDC6A3C0OX)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
ETHYLPARABEN (UNII: 14255EXE39)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
XANTHAN GUM (UNII: TTV12P4NEE)
CERAMIDE 1 (UNII: 5THT33P7X7)
FUCUS SERRATUS (UNII: V8K40WNW5B)
EDETATE DISODIUM (UNII: 7FLD91C86K)
AMINO ACIDS, SOY (UNII: NWB9514AZM)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETIC ACID (UNII: 9G34HU7RV0)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PEG-8 LAURATE (UNII: 762O8IWA10)
TRAMIPROSATE (UNII: 5K8EAX0G53)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
AMINOPROPYL DIMETHICONE (1000 MPA.S) (UNII: P4P48I53XH)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
DOCOSANOL (UNII: 9G1OE216XY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DESMENINOL CALCIUM (UNII: 1VK0YS654L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CERAMIDE 3 (UNII: 4370DF050B)
YEAST (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-669-17	49 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(10967-669)