Neutrogena ®

Neutrogena ®
SPL v9
SPL
SPL Set ID b10a7794-7e4f-412b-9eb2-773107ecb7fc
Route
TOPICAL
Published
Effective Date 2019-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (30 mg) Avobenzone (40 mg) Octisalate (20 mg) Octocrylene (50 mg) Oxybenzone
Inactive Ingredients
Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Alcohol Isobutane Dimethicone Trisiloxane Diethylhexyl 2,6-naphthalate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-01

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • helps prevent sunburn Sunscreen
  • 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 away from face to avoid breathing it
    • 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
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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
Questions?

Call toll-free 800-299-4786 or 215-273-8755 (collect)

www.neutrogena.com

Other Information
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Active Ingredients

Avobenzone 3%

Homosalate 8%

Octisalate 4%

Octocrylene 2%

Oxybenzone 5%

Inactive Ingredients

alcohol denat., isobutane, dimethicone, acrylates/octylacrylamide copolymer, trisiloxane, diethylhexyl 2,6 naphthalate, tocopheryl acetate, fragrance

Principal Display Panel 240 G Can Label

FAMILY SIZE

20% MORE

Neutrogena ®

Beach

Defense ®

water + sun

protection

SUNSCREEN SPRAY

Broad Spectrum SPF30

30

helioplex ®

broad spectrum uva-uvb

water resistant

(80 minutes)

#1 DERMATOLOGIST

RECOMMENDED SUNCARE

NET WT. 8.5 OZ. (240g)


Structured Label Content

Uses
  • helps prevent sunburn Sunscreen
  • 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 away from face to avoid breathing it
    • 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
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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
Questions?

Call toll-free 800-299-4786 or 215-273-8755 (collect)

www.neutrogena.com

Other Information (Other information)
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 8%

Octisalate 4%

Octocrylene 2%

Oxybenzone 5%

Inactive Ingredients (Inactive ingredients)

alcohol denat., isobutane, dimethicone, acrylates/octylacrylamide copolymer, trisiloxane, diethylhexyl 2,6 naphthalate, tocopheryl acetate, fragrance

Principal Display Panel 240 G Can Label (PRINCIPAL DISPLAY PANEL - 240 g Can Label)

FAMILY SIZE

20% MORE

Neutrogena ®

Beach

Defense ®

water + sun

protection

SUNSCREEN SPRAY

Broad Spectrum SPF30

30

helioplex ®

broad spectrum uva-uvb

water resistant

(80 minutes)

#1 DERMATOLOGIST

RECOMMENDED SUNCARE

NET WT. 8.5 OZ. (240g)


Advanced Ingredient Data


Raw Label Data

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