Indications and uses
helps prevent sunburn if used as directed with other sun protection messures (see Directions ) decreases the risk of skin cancer and early skin aging caused by sun.
Sunscreen SPF 50
- Manufacturer
- Valeant Pharmaceuticals | Product Quest Mfg
- Effective date
- 2015-11-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:29:53
Label at a glance#
ProductSunscreen SPF 50 CeraVe
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure6 sections
Dosage and administration
• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • 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 ti...
Label contents#
Full prescribing information#
Active ingredients Purpose
Titanium Dioxide 4.9% Sunscreen
Zinc Oxide 4.7% Sunscreen
Uses
- helps prevent sunburn
- if used as directed with other sun protection messures (see Directions) decreases the risk of skin cancer and early skin aging caused by 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
• apply liberally 15 minutes before sun exposure
• reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • 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
Inactive ingredients
Water, Butyloctyl Salicylate, Cetyl Dimethicone, Dimethicone, Styrene/Acrylates Copolymer, Trimethylsiloxysilicate, Dimethicone PEG-8 , Laurate, Isohexadecane, Butylene Glycol, Polysorbate 60, Trisiloxane, Arachidyl Alcohol, Polyhydroxystearic Acid, Hydrated Silica, Ceramide 3, Ceramide 6 II, Ceramide 1, Niacinamide, Cholesterol, Phytosphingosine, PEG-100 Stearate, Glyceryl Stearate, Ascorbic Acid, Avena Sativa , Oat) Kernel Extract, Arachidyl Glucoside, Beeswax, Behenyl Alcohol, Benzyl Alcohol, Stearic Acid, Bisabolol, Dipotassium Glycyrrhizate, Ehtylhexylglycerin, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pantothenic Acid/Yeast Polypeptide, PEG-8, Xanthan Gum, Polyaminopropyl Biguanide, Polymethyl Methacrylate, Alumina, Potassium Sorbate,Retinyl Palmitate, Sodium Lauroyl Lactylate, Carbomer, Tocopheryl Acetate, BHT, Disodium EDTA, Methicone, Methylisothiazolinone, Triethoxycaprylylsilane.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66490-555-02 | 2021-05-06 | C162847 | 48780-1 | 9d75b9d0-269e-f424-e053-dadaa90a57ce | 16eedcd0-604c-40d3-87ca-4f0c4137d0ec |
| 66490-555-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-269e-f424-e053-dadaa90a57ce | 16eedcd0-604c-40d3-87ca-4f0c4137d0ec |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ACRYLIC ACID | INACTIVE INGREDIENT | J94PBK7X8S | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| Arachidyl Alcohol | INACTIVE INGREDIENT | 1QR1QRA9BU | 1 | |
| Arachidyl Glucoside | INACTIVE INGREDIENT | 6JVW35JOOJ | 1 | |
| Ascorbic Acid | INACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| Benzyl Alcohol | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| Butylene Glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| Butyloctyl Salicylate | INACTIVE INGREDIENT | 2EH13UN8D3 | 1 | |
| CARBOXYPOLYMETHYLENE | INACTIVE INGREDIENT | 0A5MM307FC | 1 | |
| Ceramide 1 | INACTIVE INGREDIENT | 5THT33P7X7 | 1 | |
| Ceramide 3 | INACTIVE INGREDIENT | 4370DF050B | 1 | |
| Ceramide 6 II | INACTIVE INGREDIENT | F1X8L2B00J | 1 | |
| CETYL DIMETHICONE 45 | INACTIVE INGREDIENT | IK315POC44 | 1 | |
| Cholesterol | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| Dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| Dimethicone PEG-8 Laurate | INACTIVE INGREDIENT | 72MF9C2A18 | 1 | |
| DOCOSANOL | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL STEARATE CITRATE | INACTIVE INGREDIENT | WH8T92A065 | 1 | |
| GLYCYRRHIZINATE DIPOTASSIUM | INACTIVE INGREDIENT | CA2Y0FE3FX | 1 | |
| Hydrated Silica | INACTIVE INGREDIENT | Y6O7T4G8P9 | 1 | |
| HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) | INACTIVE INGREDIENT | 86FQE96TZ4 | 1 | |
| Isohexadecane | INACTIVE INGREDIENT | 918X1OUF1E | 1 | |
| LEVOMENOL | INACTIVE INGREDIENT | 24WE03BX2T | 1 | |
| METHICONE (20 CST) | INACTIVE INGREDIENT | 6777U11MKT | 1 | |
| Methylisothiazolinone | INACTIVE INGREDIENT | 229D0E1QFA | 1 | |
| Niacinamide | INACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| OAT | INACTIVE INGREDIENT | Z6J799EAJK | 1 | |
| PEG-100 Stearate | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| Phytosphingosine | INACTIVE INGREDIENT | GIN46U9Q2Q | 1 | |
| POLY(METHYL METHACRYLATE; 450000 MW) | INACTIVE INGREDIENT | Z47NNT4J11 | 1 | |
| Polyaminopropyl Biguanide | INACTIVE INGREDIENT | 322U039GMF | 1 | |
| POLYHYDROXYSTEARIC ACID (2300 MW) | INACTIVE INGREDIENT | YXH47AOU0F | 1 | |
| Polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| Potassium Sorbate | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| Sodium Lauroyl Lactylate | INACTIVE INGREDIENT | 7243K85WFO | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Triethoxycaprylylsilane | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) | INACTIVE INGREDIENT | 25LXE464L2 | 1 | |
| Trisiloxane | INACTIVE INGREDIENT | 9G1ZW13R0G | 1 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- Sunscreen SPF 50 CeraVe
- Titanium Dioxide - 4.90% Zinc Oxide - 4.70%
- Titanium Dioxide
- Zinc Oxide
- ZINC CATION
- Water
- Butyloctyl Salicylate
- CETYL DIMETHICONE 45
- Dimethicone
- ACRYLIC ACID
- TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)
- Dimethicone PEG-8 Laurate
- Isohexadecane
- Butylene Glycol
- Polysorbate 60
- Trisiloxane
- Arachidyl Alcohol
- POLYHYDROXYSTEARIC ACID (2300 MW)
- Hydrated Silica
- Ceramide 3
- Ceramide 6 II
- Ceramide 1
- Niacinamide
- Cholesterol
- Phytosphingosine
- PEG-100 Stearate
- GLYCERYL STEARATE CITRATE
- Ascorbic Acid
- OAT
- Arachidyl Glucoside
- YELLOW WAX
- DOCOSANOL
- Benzyl Alcohol
- Stearic Acid
- LEVOMENOL
- GLYCYRRHIZINATE DIPOTASSIUM
- Glycerin
- HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
- Xanthan Gum
- Polyaminopropyl Biguanide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66490-555 | 66490-555-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SPRAY / NASAL | 5 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION / ORAL | 450 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | EMULSION / OPHTHALMIC | 0.47 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | TABLET, COATED / ORAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTICULAR | 1 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | CAPSULE, DELAYED RELEASE / ORAL | 12 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | LIQUID / INTRAVENOUS | 1.04 %w/v | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | GEL / TOPICAL | 185 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SUPPOSITORY / VAGINAL | 0.03 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCONJUNCTIVAL | 252 mg | ||
| Cholesterol | CHOLESTEROL | 97C5T2UQ7J | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 0.32 %w/v | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRALESIONAL | 20 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | SOLUTION/ DROPS / OPHTHALMIC | 0.47 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 2350 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 0.02 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | AEROSOL, FOAM / TOPICAL | 8 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | POWDER, FOR SOLUTION / ORAL | 560 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | CAPSULE / ORAL | 7 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | GEL / TOPICAL | 7 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL / TOPICAL | 8 mg | ||
| Cholesterol | CHOLESTEROL | 97C5T2UQ7J | LOTION / TOPICAL | 20 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| Niacinamide | NIACINAMIDE | 25X51I8RD4 | GEL / TOPICAL | 25 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| Ascorbic Acid | ASCORBIC ACID | PQ6CK8PD0R | TABLET, FILM COATED / ORAL | 20 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAMUSCULAR | 225 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SUPPOSITORY / VAGINAL | NA | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | OINTMENT / TOPICAL | 2.2 %w/w | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | PASTE / ORAL | 48 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 439cb734-d389-4535-8eeb-b74f86e484d9 | 16eedcd0-604c-40d3-87ca-4f0c4137d0ec | 2015-11-20 | Warnings | 16eedcd0-604c-40d3-87ca-4f0c4137d0ec |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.