Neutrogena ®

Neutrogena ®
SPL v13
SPL
SPL Set ID 0464448b-342b-4e54-a20e-6ec6bd622889
Route
TOPICAL
Published
Effective Date 2025-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Alcohol Isobutane Dicaprylyl Carbonate Polyester-7 Neopentyl Glycol Diheptanoate .alpha.-tocopherol Acetate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-01

Description

Drug Facts


Medication Information

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
  • Danger: Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120°F (48°C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Section 55105-1
Active ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Warnings
  • For external use only
  • Do not use on damaged or broken skin
  • When using this product
  • keep out of eyes. Rinse with water to remove.
  • keep away from face to avoid breathing it
  • Stop use and ask a doctor if rash occurs
Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4-6 inches from the skin to apply. Rub in.
  • do not spray directly into face. Spray on hands and then apply to face. Rub in.
  • do not apply in windy conditions
  • use in a well-ventilated area
  • 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
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Inactive Ingredients

Alcohol Denat., Isobutane, Dicaprylyl Carbonate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate

Questions Or Comments?

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

Principal Display Panel 184 G Can Label

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND

Beach



Defense ®



water + sun



protection

sunscreen spray



BROAD SPECTRUM SPF 50

50

helioplex ®



broad spectrum uva•uvb

oxybenzone free



water resistant (80 minutes)

NET WT 6.5 OZ (184 g)


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
  • Danger: Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120°F (48°C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Section 55105-1 (55105-1)
Active ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Warnings
  • For external use only
  • Do not use on damaged or broken skin
  • When using this product
  • keep out of eyes. Rinse with water to remove.
  • keep away from face to avoid breathing it
  • Stop use and ask a doctor if rash occurs
Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4-6 inches from the skin to apply. Rub in.
  • do not spray directly into face. Spray on hands and then apply to face. Rub in.
  • do not apply in windy conditions
  • use in a well-ventilated area
  • 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 (Other information)
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Isobutane, Dicaprylyl Carbonate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel 184 G Can Label (PRINCIPAL DISPLAY PANEL - 184 g Can Label)

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND

Beach



Defense ®



water + sun



protection

sunscreen spray



BROAD SPECTRUM SPF 50

50

helioplex ®



broad spectrum uva•uvb

oxybenzone free



water resistant (80 minutes)

NET WT 6.5 OZ (184 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)