Ceramide Premiere Intense Moisture And Renewal Activation Cream Broad Spectrum Sunscreen Spf 30

Ceramide Premiere Intense Moisture And Renewal Activation Cream Broad Spectrum Sunscreen Spf 30
SPL v3
SPL
SPL Set ID b3358bfd-7fe5-33e2-e053-2a95a90ac2ea
Route
TOPICAL
Published
Effective Date 2020-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxybenzone (4 mg) Octinoxate (7.5 mg) Octocrylene (3 mg) Avobenzone (2 mg) Octisalate (5 mg)
Inactive Ingredients
Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Cholesterol Glycerin Phytosphingosine Ethylparaben Potassium Sorbate Polysorbate 20 Stannic Oxide Butyloctyl Salicylate Xanthan Gum Ceramide 1 Fucus Serratus Edetate Disodium Amino Acids, Soy Butylphenyl Methylpropional Dimethicone Edetic Acid Mica Water Butylene Glycol Medium-chain Triglycerides Dimethyl Capramide Ceramide 6 Ii Peg-100 Stearate Sodium Dodecylbenzenesulfonate Sodium Hydroxide Peg-8 Laurate Tramiprosate Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Aminopropyl Dimethicone (1000 Mpa.s) Isomethyl-.alpha.-ionone Hydroxycitronellal Carbomer Homopolymer, Unspecified Type Propylparaben Methylparaben Docosanol Phenoxyethanol Desmeninol Calcium Sodium Benzoate Titanium Dioxide Hydrogenated Polybutene (1300 Mw) Petrolatum Glyceryl Monostearate Hydrogenated Soybean Lecithin Ceramide 3 Yeast

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-06
Description

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

Purpose

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

Medication Information

Indications and Usage
  • 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
Purpose

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

Dosage and Administration
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
Description

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

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

Section 50565-1

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

Section 55105-1

Sunscreen

Artwork

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.

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).

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

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.

Structured Label Content

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

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)

Sunscreen

Artwork

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.

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).

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

Directions for Sunscreen Use (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.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:57.329538 · Updated: 2026-03-14T23:12:00.901105