FDA.reportPublic FDA data

Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus

Manufacturer
Knowlton Development Corporation Inc
Effective date
2019-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:04:08

Label at a glance#

ProductNeutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus
Active ingredientZINC 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 and evenly 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 S...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (21.6%)

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 and evenly 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 small parts, which could cause a choking hazard

Inactive ingredients

INACTIVE INGREDIENT SECTION

Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Polyethylene, Paraffin, Silica, Neopentyl Glycol Diethylhexanoate, Ozokerite, Isopropyl Myristate, Adipic Acid/Diglycol Crosspolymer, Triethoxycaprylylsilane, Neopentyl Glycol Diisostearate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil

Questions?

OTC - QUESTIONS SECTION

800-582-4048; Outside US, dial collect 215-273-8755.

neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 42 g Canister Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neutrogena ®

#1 DERMATOLOGIST RECOMMENDED BRAND

Sheer Zinc

kids

mineral

sunscreen stick
BROAD SPECTRUM SPF 50+

50+

NEW

BIG STICK

water resistant
(80 minutes)

NET WT 1.5 OZ (42g)

PRINCIPAL DISPLAY PANEL - 42 g Canister Label
PRINCIPAL DISPLAY PANEL - 42 g Canister Label

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54565-162954565-1629-1

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
NameUNIIKind
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
PARAFFINI9O0E3H2ZEIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
CERESINQ1LS2UJO3AIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)R9TPS68K19IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
NEOPENTYL GLYCOL DIISOSTEARATE4M6OQ34JWWIACT
CAPRYLYL GLYCOL00YIU5438UIACT
OAT KERNEL OIL3UVP41R77RIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

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
9625c032-b44d-7422-e053-2a95a90a1dc99625ccee-6d18-55ca-e053-2995a90aa1e72019-10-30WarningsExact identifier
spl id: 9625c032-b44d-7422-e053-2a95a90a1dc9
spl set id: 9625ccee-6d18-55ca-e053-2995a90aa1e7

Reported adverse events (FAERS/openFDA)#

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