Neutrogena Pure and Free Baby Faces

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2019-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:51:58

Label at a glance#

ProductNeutrogena Pure and Free Baby Faces Ultra Gentle Sunscreen Broad Spectrum SPF45 Plus
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure11 sections

Indications and uses

Helps prevent sunburn (Optional) 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 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 value of SPF of 15 or higher and other sun protection measures including: Limit time in...

Storage and handling

Protect this product from excessive heat and direct sun May stain some fabrics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5.1%
Zinc Oxide 2.9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • (Optional) 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
  • 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 value of 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-sleeved shirts, pants hats, and sunglasses
  • Children under 6 months: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aluminum Hydroxide, C12-15 Alkyl Benzoate, Carbomer, Cetyl Alcohol, Cetyl Dimethicone, Cetyl Hydroxyethylcellulose, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dimethicone Crosspolymer , Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium Phosphate, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Hydrated Silica, Isopropyl Myristate, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-4 Isostearate, Silica, Sodium Hydroxide, Sodium Phosphate, Stearic Acid, Styrene/Acrylates Copolymer, riethoxycaprylylsilane, Trisiloxane, Water

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 - 73 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neutrogena®

pure & free®
baby faces
ultra gentle cream

SUNSCREEN
Broad Spectrum
SPF 45+

pureSCREEN®
broad spectrum uva-uvb

TEAR FREE
100% naturally sourced sunscreens
hypoallergenic
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

2.5 FL OZ (73mL)

Principal Display Panel - 73 mL Tube Carton
Principal Display Panel - 73 mL Tube Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQ1
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN01
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3P1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Hexyl LaurateINACTIVE INGREDIENT4CG9F9W01Q1
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P91
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJS1
Magnesium SulfateINACTIVE INGREDIENTDE08037SAB1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Polyglyceryl-4 IsostearateINACTIVE INGREDIENT820DPX33S71
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
sodium PhosphateINACTIVE INGREDIENTSE337SVY371
Sodium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENT22ADO53M6F1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08E1
TrisiloxaneINACTIVE INGREDIENT9G1ZW13R0G1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10812-42010812-420-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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 8 · 450 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium PhosphateSODIUM PHOSPHATESE337SVY37TABLET / ORAL16 mgExact identifier — unii candidate
24 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Phosphate, Dibasic, AnhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / SUBCUTANEOUS0.11 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAMUSCULAR176 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium Phosphate, Dibasic, AnhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRASYNOVIAL3 mgExact identifier — unii candidate
48 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium Phosphate, Dibasic, AnhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
sodium PhosphateSODIUM PHOSPHATESE337SVY37INJECTION / INTRAMUSCULAR10.6 mgExact identifier — unii candidate
24 equally ranked IID candidates
Sodium Phosphate, Dibasic, AnhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINSERT / INTRAOCULAR0.02 mgExact identifier — unii candidate
48 equally ranked IID candidates
Magnesium SulfateMAGNESIUM SULFATEDE08037SABTABLET / ORAL2.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium PhosphateSODIUM PHOSPHATESE337SVY37INJECTION / INTRAVENOUS10.6 mgExact identifier — unii candidate
24 equally ranked IID candidates
sodium PhosphateSODIUM PHOSPHATESE337SVY37INJECTION, SOLUTION / INTRAMUSCULAR0.14 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium Phosphate, Dibasic, AnhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / RECTALNAExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSOINTMENT / TOPICAL35 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium PhosphateSODIUM PHOSPHATESE337SVY37INJECTION / ORAL10.35 mgExact identifier — unii candidate
24 equally ranked IID candidates
Sodium Phosphate, Dibasic, AnhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, DELAYED RELEASE / ORAL43 mgExact identifier — unii candidate
48 equally ranked IID candidates
Sodium Phosphate, Dibasic, AnhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FAEROSOL, FOAM / TOPICAL0.09 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
Sodium Phosphate, Dibasic, AnhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION/ DROPS / TOPICAL0.14 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Phosphate, Dibasic, AnhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCREAM / TOPICAL0.36 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
Aluminum HydroxideALUMINUM HYDROXIDE5QB0T2IUN0TABLET / ORAL50 mgExact identifier — unii candidate
4 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
182b1083-1bd1-4162-a9a3-552e67b5c9c046b024a5-5af6-43ae-adb5-0340ec23d5042020-05-07WarningsExact identifier
spl set id: 46b024a5-5af6-43ae-adb5-0340ec23d504

Reported adverse events (FAERS/openFDA)#

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