FDA.reportPublic FDA data

CERAMIDE PREMIERE BROAD SPECTRUM SPF 30

Manufacturer
REVLON | Englewood Lab. INC.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:29:25

Label at a glance#

ProductCERAMIDE PREMIERE BROAD SPECTRUM SPF 30
Active ingredientOXYBENZONE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE
Label structure10 sections

Indications and 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

Dosage and administration

- 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, pa...

Label contents#

Full prescribing information#

Active Ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

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

INSTRUCTIONS FOR USE SECTION

- 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 SECTION

- 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

OTC - WHEN USING SECTION

- 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.

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children. If product is swallowed, get medical help or contact a poison control center right away.

OTC - PURPOSE SECTION

Sunscreen

Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

premier cartonpremier carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10967-669-172025-12-29C16284748780-1d6a99b39-ff6f-a426-e053-dadaa90af4c2CERAMIDE PREMIERE INTENSE MOISTURE AND RENEWAL ACTIVATION CREAM BROAD SPECTRUM SUNSCREEN SPF 30
10967-669-172023-07-28C16284748780-1d6a99b39-ff6f-a426-e053-dadaa90af4c2CERAMIDE PREMIERE INTENSE MOISTURE AND RENEWAL ACTIVATION CREAM BROAD SPECTRUM SUNSCREEN SPF 30
10967-669-172022-02-09C16284748780-1d6a99b39-ff6f-a426-e053-dadaa90af4c2CERAMIDE PREMIERE INTENSE MOISTURE AND RENEWAL ACTIVATION CREAM BROAD SPECTRUM SUNSCREEN SPF 30
10967-669-172022-01-28C16284748780-1d6a99b39-ff6f-a426-e053-dadaa90af4c2CERAMIDE PREMIERE INTENSE MOISTURE AND RENEWAL ACTIVATION CREAM BROAD SPECTRUM SUNSCREEN SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-669-17CERAMIDE PREMIERE BROAD SPECTRUM SPF 3049 g in 1 JAREMULSION493

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-66910967-669-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYBENZONE95OOS7VE0YACTIB
OCTINOXATE4Y5P7MUD51ACTIB
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
CHOLESTEROL97C5T2UQ7JIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
GLYCERINPDC6A3C0OXIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
ETHYLPARABEN14255EXE39IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POLYSORBATE 207T1F30V5YHIACT
STANNIC OXIDEKM7N50LOS6IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
XANTHAN GUMTTV12P4NEEIACT
CERAMIDE 15THT33P7X7IACT
FUCUS SERRATUSV8K40WNW5BIACT
EDETATE DISODIUM7FLD91C86KIACT
AMINO ACIDS, SOYNWB9514AZMIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
DIMETHICONE92RU3N3Y1OIACT
EDETIC ACID9G34HU7RV0IACT
MICAV8A1AW0880IACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHYL CAPRAMIDEO29Y6X2JEZIACT
CERAMIDE 6 IIF1X8L2B00JIACT
OCTISALATE4X49Y0596WACTIB
PEG-100 STEARATEYD01N1999RIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
SODIUM HYDROXIDE55X04QC32IIACT
PEG-8 LAURATE762O8IWA10IACT
TRAMIPROSATE5K8EAX0G53IACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
AMINOPROPYL DIMETHICONE (1000 MPA.S)P4P48I53XHIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CERAMIDE PREMIERE BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONEREVLONb3358bfd-7fe5-33e2-e053-2a95a90ac2ea2025-12-29WarningsExact identifier
ndc (package): 10967-669-17
ndc (product): 10967-669
ndc11 (package): 10967066917
spl id: 471d8a24-eac2-ccb8-e063-6294a90aa3ec
spl set id: b3358bfd-7fe5-33e2-e053-2a95a90ac2ea