CeraVe

Manufacturer: Valeant Pharmaceuticals North America LLC | Product Quest Mfg, LLC
Effective date: 2017-02-17
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:19:20

Label at a glance#

ProductCeraVe Sunscreen Broad Spectrum SPF 50

Active ingredientTitanium Dioxide, Zinc Oxide

Label structure9 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: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: Ask a doctor • 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 value of 15 or higher and other...

Contacts and useful links#

PhoneLabel contact(800) 321-4576

Websitewww.cerave.com

www.cerave.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

*Active Ingredients*	*Purpose*
Titanium Dioxide 6%	Sunscreen
Zinc Oxide 4.7%	Sunscreen

Uses

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 aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only
Do not use on damaged or broken skin
Stop use and ask a doctor if rash occurs
When using this product keep out of eyes. Rinse with water to remove.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.
Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
Children under 6 months: Ask a doctor
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 value 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-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Neopentyl Glycol Diethylhexanoate, Paraffin, Euphobia Cerifera (Candelilla) Wax, Ozokerite, Dimethicone, Beeswax, Polyethylene, Cetyl Alcohol, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Phytosphingosine, Sodium Hyaluronate, Polyhydrostearic Acid, Aluminum Hydroxide, Stearic Acid, BHT, Carbomer, Triethoxycaprylylsilane, Isostearic Acid, Sodium Lauroyl Lactylate, Xanthan Gum

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

Toll-free number (800) 321-4576
www.cerave.com

PRINCIPAL DISPLAY PANEL - 0.47 OZ Sunscreen Stick SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CeraVe^®
DEVELOPED WITH DERMATOLOGISTS

Sunscreen
BROAD SPECTRUM SPF 50

STICK SPF 50

InVisibleZinc

Net Wt. 0.47 OZ (13.32 g)

CeraVe SPF 50 Sunscreen Stick Blister Card

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0187-2208-01	2021-05-12	C162847	48780-1	9d75b9d0-81a9-f424-e053-dadaa90a57ce	CeraVe ® Sunscreen Stick SPF 50
0187-2208-01	2020-01-31	C162847	48780-1	9d75b9d0-81a9-f424-e053-dadaa90a57ce	CeraVe ® Sunscreen Stick SPF 50

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	1
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	1
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	1
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	1
CERAMIDE 1	INACTIVE INGREDIENT	5THT33P7X7	1
CERAMIDE 3	INACTIVE INGREDIENT	4370DF050B	1
CERAMIDE 6 II	INACTIVE INGREDIENT	F1X8L2B00J	1
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	1
ISOSTEARIC ACID	INACTIVE INGREDIENT	X33R8U0062	1
NEOPENTYL GLYCOL DIETHYLHEXANOATE	INACTIVE INGREDIENT	U68ZV6W62C	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	1
PHYTOSPHINGOSINE	INACTIVE INGREDIENT	GIN46U9Q2Q	1
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	1
SODIUM LAUROYL LACTYLATE	INACTIVE INGREDIENT	7243K85WFO	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

CeraVe Sunscreen Broad Spectrum SPF 50
Titanium Dioxide, Zinc Oxide
Titanium Dioxide
Zinc Oxide
ALKYL (C12-15) BENZOATE
BUTYLOCTYL SALICYLATE
NEOPENTYL GLYCOL DIETHYLHEXANOATE
PARAFFIN
CANDELILLA WAX
CERESIN
DIMETHICONE
YELLOW WAX
HIGH DENSITY POLYETHYLENE
CETYL ALCOHOL
CERAMIDE NP
CERAMIDE AP
CERAMIDE 1
CHOLESTEROL
PHYTOSPHINGOSINE
HYALURONATE SODIUM
POLYHYDROXYSTEARIC ACID (2300 MW)
ALUMINUM HYDROXIDE
STEARIC ACID
BUTYLATED HYDROXYTOLUENE
TRIETHOXYCAPRYLYLSILANE
ISOSTEARIC ACID
SODIUM LAUROYL LACTYLATE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0187-2208	0187-2208-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Titanium Dioxide	15FIX9V2JP	ACTIB
Zinc Oxide	SOI2LOH54Z	ACTIB
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
BUTYLOCTYL SALICYLATE	2EH13UN8D3	IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATE	U68ZV6W62C	IACT
PARAFFIN	I9O0E3H2ZE	IACT
CANDELILLA WAX	WL0328HX19	IACT
CERESIN	Q1LS2UJO3A	IACT
DIMETHICONE	92RU3N3Y1O	IACT
YELLOW WAX	2ZA36H0S2V	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
CETYL ALCOHOL	936JST6JCN	IACT
CERAMIDE NP	4370DF050B	IACT
CERAMIDE AP	F1X8L2B00J	IACT
CERAMIDE 1	5THT33P7X7	IACT
CHOLESTEROL	97C5T2UQ7J	IACT
PHYTOSPHINGOSINE	GIN46U9Q2Q	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
POLYHYDROXYSTEARIC ACID (2300 MW)	YXH47AOU0F	IACT
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
STEARIC ACID	4ELV7Z65AP	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
ISOSTEARIC ACID	X33R8U0062	IACT
SODIUM LAUROYL LACTYLATE	7243K85WFO	IACT
XANTHAN GUM	TTV12P4NEE	IACT

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 3 · 173 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
ALUMINUM HYDROXIDE	ALUMINUM HYDROXIDE	5QB0T2IUN0	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	GEL / TOPICAL		463 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SOAP / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SYSTEM / TRANSDERMAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.02 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	INJECTION, SUSPENSION / INTRA-ARTICULAR		23 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / TOPICAL	94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CAPSULE, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CREAM / TOPICAL	54.5 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CERESIN	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
ALUMINUM HYDROXIDE	ALUMINUM HYDROXIDE	5QB0T2IUN0	CAPSULE / ORAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, EXTENDED RELEASE / ORAL	0.64 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE, EXTENDED RELEASE / ORAL	4.53 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
eaab9ffa-bef2-4b84-a56c-cc0a5dbad828			5251aa24-287e-4a23-a6a7-ef6d696904f6	2017-02-17	Warnings	Exact identifier spl set id: 5251aa24-287e-4a23-a6a7-ef6d696904f6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.