Neutrogena ®

Neutrogena ®
SPL v9
SPL
SPL Set ID 41ff1a98-69ff-4d7a-bc89-d986a803cee3
Route
TOPICAL
Published
Effective Date 2025-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (216 mg)
Inactive Ingredients
Octyldodecyl Neopentanoate Alkyl (c12-15) Benzoate Paraffin Silicon Dioxide Neopentyl Glycol Diethylhexanoate Ceresin Isopropyl Myristate Adipic Acid/diglycol Crosspolymer (20000 Mpa.s) Triethoxycaprylylsilane Neopentyl Glycol Diisostearate Caprylyl Glycol Oat Kernel Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-05

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

Directions
  • apply liberally 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 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
Questions?

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

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

Zinc Oxide 21.6%

Inactive Ingredients

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

Principal Display Panel 13 G Stick Label

Neutrogena ®

Pure & Free ®

baby

zinc oxide

sunscreen stick

BROAD SPECTRUM

SPF 50

pureSCREEN ®



broad spectrum uva.uvb

ideal for delicate skin



water resistant

(80 minutes)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 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 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
Questions?

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

Other Information (Other information)
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
  • package contains small parts, which could cause a choking hazard
Active Ingredients (Active ingredients)

Zinc Oxide 21.6%

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 13 G Stick Label (PRINCIPAL DISPLAY PANEL - 13 g Stick Label)

Neutrogena ®

Pure & Free ®

baby

zinc oxide

sunscreen stick

BROAD SPECTRUM

SPF 50

pureSCREEN ®



broad spectrum uva.uvb

ideal for delicate skin



water resistant

(80 minutes)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)