Neutrogena ®

Neutrogena ®
SPL v8
SPL
SPL Set ID 75f81b2d-cabc-443f-b4b5-76bd2321826b
Route
TOPICAL
Published
Effective Date 2021-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Octocrylene (40 mg) Oxybenzone (60 mg) Avobenzone (30 mg) Homosalate (150 mg)
Inactive Ingredients
Alcohol Isobutane Octyldodecyl Neopentanoate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Diethylhexyl 2,6-naphthalate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-05

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 44425-7
  • 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 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
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
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 15%, Octisalate 5%, Octocrylene 4%, Oxybenzone 6%

Inactive Ingredients

Alcohol Denat., Isobutane, Octyldodecyl Neopentanoate, Acrylates/Octylacrylamide Copolymer, Fragrance, Tocopheryl Acetate, Diethylhexyl 2,6 Naphthalate

Principal Display Panel 184 G Can Label

Neutrogena ®

#1 DERMATOLOGIST RECOMMENDED BRAND

Beach

Defense ®

water + sun

protection

sunscreen spray

BROAD SPECTRUM SPF 70

70

helioplex ®

broad spectrum uva-uvb

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 44425-7 (44425-7)
  • 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 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
Purpose

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
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 15%, Octisalate 5%, Octocrylene 4%, Oxybenzone 6%

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Isobutane, Octyldodecyl Neopentanoate, Acrylates/Octylacrylamide Copolymer, Fragrance, Tocopheryl Acetate, Diethylhexyl 2,6 Naphthalate

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

Neutrogena ®

#1 DERMATOLOGIST RECOMMENDED BRAND

Beach

Defense ®

water + sun

protection

sunscreen spray

BROAD SPECTRUM SPF 70

70

helioplex ®

broad spectrum uva-uvb

water resistant (80 minutes)

NET WT. 6.5 OZ. (184 g)


Advanced Ingredient Data


Raw Label Data

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