neutrogena ®

neutrogena ®
SPL v7
SPL
SPL Set ID 5c1a0437-c269-4cd3-b91a-e2de799b853e
Route
topical
Published
Effective Date 2020-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (150 mg) octisalate (50 mg) octocrylene (100 mg)
Inactive Ingredients
alcohol .alpha.-tocopherol acetate isobutane butyloctyl salicylate dicaprylyl carbonate diethylhexyl 2,6-naphthalate polyester-7 acrylate/isobutyl methacrylate/n-tert-octylacrylamide copolymer (75000 mw) neopentyl glycol diheptanoate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-10-05

Description

Drug Facts


Medication Information

Warnings
  • For external use only
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
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, Butyloctyl Salicylate, Dicaprylyl Carbonate, Diethylhexyl 2,6-Naphthalate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate

Description

Drug Facts

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 15% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Questions Or Comments?

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

Principal Display Panel 141 G Can Label

Neutrogena ®

#1 DERMATOLOGIST RECOMMENED BRAND

COOL DRY

SPORT

sunscreen spray

BROAD SPECTRUM SPF 70

70

helioplex ®

broad spectrum uva.uvb

stays on through sweet

oxybenzone free

water resistant (80 minutes)

NET WT 5.0 OZ (141 g)


Structured Label Content

Warnings
  • For external use only
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
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, Butyloctyl Salicylate, Dicaprylyl Carbonate, Diethylhexyl 2,6-Naphthalate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate

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 15% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel 141 G Can Label (PRINCIPAL DISPLAY PANEL - 141 g Can Label)

Neutrogena ®

#1 DERMATOLOGIST RECOMMENED BRAND

COOL DRY

SPORT

sunscreen spray

BROAD SPECTRUM SPF 70

70

helioplex ®

broad spectrum uva.uvb

stays on through sweet

oxybenzone free

water resistant (80 minutes)

NET WT 5.0 OZ (141 g)


Advanced Ingredient Data


Raw Label Data

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