MedPath

Neutrogena Clear Face Breakout Free oil Free Sunscreen Broad Spectrum SPF 50

Neutrogena Clear Face BREAKOUT FREE oil-free sunscreen BROAD SPECTRUM SPF 50

Approved
Approval ID

10ca67ca-c372-44a9-8933-84cce9fb9934

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 1, 2025

Manufacturers
FDA

Kenvue Brands LLC

DUNS: 118772437

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

avobenzone, homosalate, octisalate, and octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69968-0662
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
avobenzone, homosalate, octisalate, and octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 1, 2025
FDA Product Classification

INGREDIENTS (34)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CETYL DIMETHICONE 25Inactive
Code: U4AS1BW4ZB
Classification: IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERInactive
Code: V5RS026Q0H
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARETH-100Inactive
Code: 4OH5W9UM87
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
STEARETH-2Inactive
Code: V56DFE46J5
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
ETHYLHEXYL STEARATEInactive
Code: EG3PA2K3K5
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
LEVOMENOLInactive
Code: 24WE03BX2T
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
YEAST MANNANInactive
Code: 91R887N59P
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CAPRYLOYL GLYCINEInactive
Code: 8TY5YO42NJ
Classification: IACT
CINNAMON BARK OILInactive
Code: XE54U569EC
Classification: IACT
TRIDECETH-6Inactive
Code: 3T5PCR2H0C
Classification: IACT
CEDRUS ATLANTICA BARKInactive
Code: ITP1Q41UPF
Classification: IACT
SARCOSINEInactive
Code: Z711V88R5F
Classification: IACT
PURSLANEInactive
Code: M6S840WXG5
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 100 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)Inactive
Code: S7ZA3CCJ4M
Classification: IACT
OCTOCRYLENEActive
Quantity: 100 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/14/2025

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Neutrogena**®**

DERMATOLOGIST RECOMMENED BRAND

Clear Face

BREAKOUT FREE

oil-free

sunscreen

BROAD SPECTRUM SPF 50

50

helioplex**®******


** broad spectrum uva.uvb**

won't cause breakouts

oxybenzone free

water resistant (80 minutes)

3.0 FL OZ (88 mL)

Neutrogena_1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/7/2021

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/14/2025

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/7/2021

Active Ingredients

Purpose

Avobenzone 3%

Sunscreen

Homosalate 10%

Sunscreen

Octisalate 5%

Sunscreen

Octocrylene 10%

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 1/7/2021

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/7/2021

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/7/2021

Other Information

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/7/2021

Inactive Ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/7/2021

Questions?

Call toll-free800-582-4048 or215-273-8755 (collect). www.neutrogena.com

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