Neutrogena ®

Neutrogena ®
SPL v13
SPL
SPL Set ID 39710a1a-fe8c-41f2-b60c-db3e99d60a86
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
Isobutane Dicaprylyl Carbonate Polyester-7 Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Neopentyl Glycol Diheptanoate Alcohol .alpha.-tocopherol Acetate

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
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.
  • keep away from face to avoid breathing it
Section 50570-1
  • Do not use on damaged or broken skin
Section 55105-1
Active ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Warnings
  • For external use only
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 240 G Can Label

VALUE SIZE



Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

Beach



Defense ®

water + sun



protection

sunscreen spray



BROAD SPECTRUM SPF 60+

60+

helioplex ®



broad spectrum uva•uvb

oxybenzone free

water resistant (80 minutes)

NET WT. 8.5 OZ. (240 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
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.
  • keep away from face to avoid breathing it
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
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
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 240 G Can Label (PRINCIPAL DISPLAY PANEL - 240 g Can Label)

VALUE SIZE



Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

Beach



Defense ®

water + sun



protection

sunscreen spray



BROAD SPECTRUM SPF 60+

60+

helioplex ®



broad spectrum uva•uvb

oxybenzone free

water resistant (80 minutes)

NET WT. 8.5 OZ. (240 g)


Advanced Ingredient Data


Raw Label Data

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