OTC Medication Information: Neutrogena Clear Face Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30

NEUTROGENA CLEAR FACE BREAKOUT FREE OIL FREE SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate and octocrylene lotion
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients Purpose
Avobenzone 2.5% Sunscreen
Homosalate 8% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 8% Sunscreen

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

Warnings

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • apply generously and evenly 15 minutes before sun exposure
  • 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
  • store at 20°C to 25°C (68°F- 77°F)
  • protect from freezing

Inactive ingredients

Water, Silica, Cetyl Dimethicone, Styrene/Acrylates Copolymer, C12-15 Alkyl Benzoate, Ethylhexylglycerin, Steareth-100, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Caprylyl, Glycol, Sodium Polyacrylate, Dimethicone, Polyester-7, Chlorphenesin, Steareth-2, Ethylhexyl Stearate, Disodium EDTA, Propylene Glycol, Neopentyl Glycol Diheptanoate, Bisabolol, Acrylates/Dimethicone Copolymer, Butylene Glycol, BHT, Mannan, Xanthan Gum, Capryloyl, Glycine, Trideceth-6, Sarcosine, Cedrus Atlantica Bark Extract, Cinnamomum Zeylanicum Bark Extract, Portulaca Oleracea Extract

Questions?

Call toll‐free 800-582-4048 or 215‐273‐8755 (collect). www.neutrogena.com

Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL — 88 mL Tube Label

Neutrogena ®
#1 DERMATOLOGIST RECOMMENDED BRAND

Clear Face
BREAKOUT FREE
oil-free
sunscreen BROAD SPECTRUM SPF 30

30

helioplex ®
broad spectrum uva•uvb

won’t cause breakouts
oxybenzone free

water resistant (80 minutes)

3.0 FL OZ (88 mL)

Principal Display Panel -- 88 mL Tube Label
(click image for full-size original)
NEUTROGENA CLEAR FACE BREAKOUT FREE OIL FREE SUNSCREEN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, and octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0571
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 25 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 80 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 80 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SILICON DIOXIDE
ALKYL (C12-15) BENZOATE
ETHYLHEXYLGLYCERIN
STEARETH-100
ALUMINUM STARCH OCTENYLSUCCINATE
PHENOXYETHANOL
CAPRYLYL GLYCOL
DIMETHICONE
POLYESTER-7
CHLORPHENESIN
STEARETH-2
ETHYLHEXYL STEARATE
EDETATE DISODIUM ANHYDROUS
PROPYLENE GLYCOL
NEOPENTYL GLYCOL DIHEPTANOATE
LEVOMENOL
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER
BUTYLENE GLYCOL
BUTYLATED HYDROXYTOLUENE
YEAST MANNAN
XANTHAN GUM
CAPRYLOYL GLYCINE
TRIDECETH-6
SARCOSINE
CEDRUS ATLANTICA BARK
CINNAMON BARK OIL
PURSLANE
CETYL DIMETHICONE 25
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0571-3 88 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/07/2019
Labeler — Johnson & Johnson Consumer Inc. (002347102)

Revised: 04/2021 Johnson & Johnson Consumer Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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