Neutrogena Pure and Free Baby

Manufacturer: Johnson & Johnson Consumer Inc.
Effective date: 2021-06-09
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 22:43:39

Label at a glance#

ProductNeutrogena Pure and Free Baby Sunscreen Broad Spectrum SPF60 Plus

Active ingredientTITANIUM DIOXIDE, ZINC OXIDE

Label structure11 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 generously 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 ...

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 6%
Zinc Oxide 4.7%

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 generously 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

Aluminum Hydroxide, Beeswax, BHT, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetyl Alcohol, Dimethicone, Euphorbia Cerifera (Candelilla) Wax, Isostearic Acid, Neopentyl Glycol Diethylhexanoate, Neopentyl Glycol Diisostearate , Ozokerite, Paraffin, Polyethylene, Stearic Acid, Triethoxycaprylylsilane

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corporation, Los Angeles, CA 90045

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
delicate skin
water resistant
(80 minutes)

#1 DERMATOLOGIST RECOMMENDED SUNCARE

NET WT
0.47 OZ
(13g)

Principal Display Panel - 13 g Cylinder Blister Pack

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
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
High Density Polyethylene	INACTIVE INGREDIENT	UG00KM4WR7	1
Isostearic Acid	INACTIVE INGREDIENT	X33R8U0062	1
Neopentyl Glycol Diethylhexanoate	INACTIVE INGREDIENT	U68ZV6W62C	1
Neopentyl Glycol Diisostearate	INACTIVE INGREDIENT	4M6OQ34JWW	1
Paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	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 · 19 matching rows.

Neutrogena Pure and Free Baby Sunscreen Broad Spectrum SPF60 Plus
Titanium Dioxide and Zinc Oxide
ALUMINUM HYDROXIDE
YELLOW WAX
BUTYLATED HYDROXYTOLUENE
BUTYLOCTYL SALICYLATE
ALKYL (C12-15) BENZOATE
CETYL ALCOHOL
DIMETHICONE
CANDELILLA WAX
ISOSTEARIC ACID
NEOPENTYL GLYCOL DIETHYLHEXANOATE
NEOPENTYL GLYCOL DIISOSTEARATE
PARAFFIN
HIGH DENSITY POLYETHYLENE
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
TITANIUM DIOXIDE
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10812-324	10812-324-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
YELLOW WAX	2ZA36H0S2V	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
BUTYLOCTYL SALICYLATE	2EH13UN8D3	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
CETYL ALCOHOL	936JST6JCN	IACT
DIMETHICONE	92RU3N3Y1O	IACT
CANDELILLA WAX	WL0328HX19	IACT
ISOSTEARIC ACID	X33R8U0062	IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATE	U68ZV6W62C	IACT
NEOPENTYL GLYCOL DIISOSTEARATE	4M6OQ34JWW	IACT
PARAFFIN	I9O0E3H2ZE	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB

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 · 127 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Aluminum Hydroxide	ALUMINUM HYDROXIDE	5QB0T2IUN0	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 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
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 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
Stearic Acid	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
Aluminum Hydroxide	ALUMINUM HYDROXIDE	5QB0T2IUN0	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Isostearic Acid	ISOSTEARIC ACID	X33R8U0062	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 3 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
Stearic Acid	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	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
Stearic Acid	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 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
Stearic Acid	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Isostearic Acid	ISOSTEARIC ACID	X33R8U0062	CREAM / TOPICAL		100 mg	Exact identifier — unii candidate 3 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	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
High Density Polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	JELLY / VAGINAL	42.6 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 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	TABLET, COATED / ORAL	25 mg		Exact identifier — unii candidate 18 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	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 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	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 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
Paraffin	PARAFFIN	I9O0E3H2ZE	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 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	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii candidate 11 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
Aluminum Hydroxide	ALUMINUM HYDROXIDE	5QB0T2IUN0	TABLET / ORAL	50 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	CAPSULE, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Isostearic Acid	ISOSTEARIC ACID	X33R8U0062	GEL / TOPICAL		20 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 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
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 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
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	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
Paraffin	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 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
Yellow Wax	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 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	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 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
c4503ca6-69bb-9505-e053-2995a90a590c			e5ebaf46-092e-43c5-905b-55aeee0be904	2021-06-09	Warnings	Exact identifier spl id: c4503ca6-69bb-9505-e053-2995a90a590c spl set id: e5ebaf46-092e-43c5-905b-55aeee0be904

Reported adverse events (FAERS/openFDA)#

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