Neutrogena Pure and Free Baby Sunscreen

Manufacturer: Johnson & Johnson Consumer Inc.
Effective date: 2019-03-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:29:04

Label at a glance#

ProductNeutrogena Pure and Free Baby Sunscreen Broad Spectrum SPF60 Plus

Active ingredientTitanium Dioxide, Zinc Oxide

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 ensure complete coverage to the area above the lip, nose, and tops of ears. 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 value o...

Storage and handling

protect this product from excessive heat and direct sun may stain some fabrics package contains some small parts, which could cause a choking hazard

Contacts and useful links#

PhoneLabel contact800-299-4786

PhoneLabel contact215-273-8755

Websitewww.neutrogena.com

www.neutrogena.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8%
Zinc Oxide 6.8%

Purpose

OTC - PURPOSE SECTION

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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
ensure complete coverage to the area above the lip, nose, and tops of ears.
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 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
children under 6 months of age: Ask a doctor

Other Information

STORAGE AND HANDLING SECTION

protect this product from excessive heat and direct sun
may stain some fabrics
package contains some small parts, which could cause a choking hazard

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, BHT, C12-15 Alkyl Benzoate, Dimethicone, Dipropylene Glycol Dibenzoate, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Neopentanoate, Ozokerite, Paraffin, Phenyl Trimethicone, Polyethylene, Polyhydroxystearic Acid, PPG-15 Stearyl Ether Benzoate, Triethoxycaprylylsilane

Questions or comments?

OTC - QUESTIONS SECTION

Visit www.neutrogena.com or call toll-free 800-299-4786 or 215-273-8755 ( collect)

PRINCIPAL DISPLAY PANEL - 13 g Cylinder Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neutrogena^®
pure & free^®
baby
SUNSCREEN

Broad Spectrum
SPF 60+
pureSCREEN^®
broad spectrum uva•uvb

100%
naturally-sourced
sunscreen
ingredients
fragrance free
ideal for
delecate skin
water resistant
(80 minutes)

NET WT
0.47 oz
(13 g)

#1 DERMATOLOGIST RECOMMENDED SUNCARE

Principal Display Panel - 13 g Cylinder Blister Pack

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10812-443-01	2020-10-08	C162847	48780-1	ab0e2407-32da-f274-e053-dbdaa90a6471	Pure & Free Baby Sunscreen Stick – Broad Spectrum SPF 60+
10812-443-01	2020-09-27	C162847	48780-1	ab0e2407-32da-f274-e053-dbdaa90a6471	Pure & Free Baby Sunscreen Stick – Broad Spectrum SPF 60+
10812-443-01	2020-09-25	C162847	48780-1	ab0e2407-32da-f274-e053-dbdaa90a6471	Pure & Free Baby Sunscreen Stick – Broad Spectrum SPF 60+
10812-443-01	2020-07-22	C162847	48780-1	ab0e2407-32da-f274-e053-dbdaa90a6471	Pure & Free Baby Sunscreen Stick – Broad Spectrum SPF 60+

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
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	1
Candelilla Wax	INACTIVE INGREDIENT	WL0328HX19	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
Dipropylene Glycol Dibenzoate	INACTIVE INGREDIENT	6OA5ZDY41O	1
High Density Polyethylene	INACTIVE INGREDIENT	UG00KM4WR7	1
Octyldodecyl Neopentanoate	INACTIVE INGREDIENT	X8725R883T	1
Paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	1
Phenyl Trimethicone	INACTIVE INGREDIENT	DR0K5NOJ4R	1
PPG-15 Stearyl Ether Benzoate	INACTIVE INGREDIENT	80D2J6361M	1
Triethoxycaprylylsilane	INACTIVE INGREDIENT	LDC331P08E	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 · 16 matching rows.

Neutrogena Pure and Free Baby Sunscreen Broad Spectrum SPF60 Plus
Titanium Dioxide and Zinc Oxide
Titanium Dioxide
Zinc Oxide
Yellow Wax
Butylated Hydroxytoluene
Alkyl (C12-15) Benzoate
Dimethicone
Dipropylene Glycol Dibenzoate
Candelilla Wax
Octyldodecyl Neopentanoate
Paraffin
Phenyl Trimethicone
High Density Polyethylene
PPG-15 Stearyl Ether Benzoate
Triethoxycaprylylsilane

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10812-443	10812-443-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Titanium Dioxide	15FIX9V2JP	ACTIB
Zinc Oxide	SOI2LOH54Z	ACTIB
Yellow Wax	2ZA36H0S2V	IACT
Butylated Hydroxytoluene	1P9D0Z171K	IACT
Alkyl (C12-15) Benzoate	A9EJ3J61HQ	IACT
Dimethicone	92RU3N3Y1O	IACT
Dipropylene Glycol Dibenzoate	6OA5ZDY41O	IACT
Candelilla Wax	WL0328HX19	IACT
Octyldodecyl Neopentanoate	X8725R883T	IACT
Paraffin	I9O0E3H2ZE	IACT
Phenyl Trimethicone	DR0K5NOJ4R	IACT
High Density Polyethylene	UG00KM4WR7	IACT
PPG-15 Stearyl Ether Benzoate	80D2J6361M	IACT
Triethoxycaprylylsilane	LDC331P08E	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 2 · 74 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Yellow Wax	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, FOR SUSPENSION / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	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
Paraffin	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 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	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
Paraffin	PARAFFIN	I9O0E3H2ZE	TABLET, EXTENDED RELEASE / ORAL		321 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	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
Paraffin	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 mg		Exact identifier — unii candidate 11 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
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET / ORAL	50 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 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	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Candelilla Wax	CANDELILLA WAX	WL0328HX19	TABLET, FILM COATED / ORAL	0.8 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE / ORAL	10 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 32 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
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	OINTMENT / RECTAL		38 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 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
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, EXTENDED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 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
Paraffin	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, LIQUID FILLED / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Candelilla Wax	CANDELILLA WAX	WL0328HX19	TABLET, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TAPE / TOPICAL	NA		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
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CREAM / TOPICAL	54.5 %w/w		Exact identifier — unii candidate 18 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
Candelilla Wax	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Candelilla Wax	CANDELILLA WAX	WL0328HX19	TABLET, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, COATED / ORAL	25 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	FILM, EXTENDED RELEASE / TRANSDERMAL		85 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Yellow Wax	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / RECTAL	NA		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
bdf07e89-008a-47dc-a6f5-01242a2ae06b			2ea5a88a-3d20-4061-b166-6c1b7e67c3d5	2020-10-07	Warnings	Exact identifier spl set id: 2ea5a88a-3d20-4061-b166-6c1b7e67c3d5

Reported adverse events (FAERS/openFDA)#

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