neutrogena ®

neutrogena ®
SPL v5
SPL
SPL Set ID 20d24c9d-9558-156d-e063-6294a90a2d1a
Route
topical
Published
Effective Date 2025-02-18
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
polyethylene octyldodecyl neopentanoate isohexadecane butyloctyl salicylate ceresin paraffin alkyl (c12-15) benzoate neopentyl glycol diisostearate dimethicone diethylhexyl 2,6-naphthalate butylated hydroxytoluene eicosyl povidone synthetic beeswax neopentyl glycol diethylhexanoate butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-10-07

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
  • apply liberally and evenly 15 minutes before sun exposure
  • ensure complete coverage to the area above the lip, nose and tops of ears
  • 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
  • After use, twist stick down prior to capping to ensure complete closure.
Other Information
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
  • protect from freezing
Inactive Ingredients

Neopentyl Glycol Diethylhexanoate, Octyldodecyl Neopentanoate, Synthetic Wax, Isohexadecane, Butyloctyl Salicylate, Ozokerite, Paraffin, Synthetic Beeswax, C12-15 Alkyl Benzoate, VP/Eicosene Copolymer, Neopentyl Glycol Diisostearate, Dimethicone, Diethylhexyl 2,6-Naphthalate, Styrene/Acrylates Copolymer, Fragrance, BHT

Description

Drug Facts

Questions?

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

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.

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
Principal Display Panel 42 G Canister Label

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND




Beach



Defense ®



water + sun protection



sunscreen stick



BROAD SPECTRUM SPF 50+

50+



helioplex ®



broad spectrum uva•uvb



water resistant (80minutes)



NET WT. 1.5 OZ. (42 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
  • apply liberally and evenly 15 minutes before sun exposure
  • ensure complete coverage to the area above the lip, nose and tops of ears
  • 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
  • After use, twist stick down prior to capping to ensure complete closure.
Other Information (Other information)
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
  • protect from freezing
Inactive Ingredients (Inactive ingredients)

Neopentyl Glycol Diethylhexanoate, Octyldodecyl Neopentanoate, Synthetic Wax, Isohexadecane, Butyloctyl Salicylate, Ozokerite, Paraffin, Synthetic Beeswax, C12-15 Alkyl Benzoate, VP/Eicosene Copolymer, Neopentyl Glycol Diisostearate, Dimethicone, Diethylhexyl 2,6-Naphthalate, Styrene/Acrylates Copolymer, Fragrance, BHT

Questions?

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

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.

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
Principal Display Panel 42 G Canister Label (PRINCIPAL DISPLAY PANEL - 42 g Canister Label)

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND




Beach



Defense ®



water + sun protection



sunscreen stick



BROAD SPECTRUM SPF 50+

50+



helioplex ®



broad spectrum uva•uvb



water resistant (80minutes)



NET WT. 1.5 OZ. (42 g)


Advanced Ingredient Data


Raw Label Data

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