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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CERAMIDE PREMIERE INTENSE MOISTURE AND RENEWAL ACTIVATION CREAM BROAD SPECTRUM SUNSCREEN SPF 30

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

premier carton

CERAMIDE PREMIERE BROAD SPECTRUM SPF 30 
octinoxate, octisalate, oxybenzone, octocrylene, avobenzone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-669
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10967-669-1749 g in 1 JAR; Type 0: Not a Combination Product02/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/06/2017
Labeler - REVLON (788820165)
Registrant - REVLON (788820165)
Establishment
NameAddressID/FEIBusiness Operations
Englewood Lab. INC.080987545manufacture(10967-669)

Revised: 2/2022
Document Id: d79a7f20-7d3d-0643-e053-2995a90a6f5b
Set id: b3358bfd-7fe5-33e2-e053-2a95a90ac2ea
Version: 2
Effective Time: 20220209
 
REVLON