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Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60

Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60

Approved
Approval ID

09ccb37b-78ee-b510-e063-6294a90a48d5

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, Octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69968-0828
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 1, 2025
FDA Product Classification

INGREDIENTS (26)

OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 100 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LEVOMENOLInactive
Code: 24WE03BX2T
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
MENTHYL LACTATE, (-)-Inactive
Code: 2BF9E65L7I
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
GREEN TEA LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
POLYURETHANE-62Inactive
Code: TBK645J3J8
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)Inactive
Code: S7ZA3CCJ4M
Classification: IACT
TRIDECETH-6Inactive
Code: 3T5PCR2H0C
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERInactive
Code: V5RS026Q0H
Classification: IACT
HOMOSALATEActive
Quantity: 135 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/10/2023

PRINCIPAL DISPLAY PANEL - 50 mL Carton Label

Neutrogena**®**

DERMATOLOGIST

RECOMMENDED BRAND

Clear Face

face serum

Sunscreen

60

BROAD SPECTRUM SPF 60

DAILY CLEAR SKIN

ANTIOXIDANT GREEN TEA

non-greasy protection.

won’t clog pores.

withHELIOPLEX****®

uva∙uvb protection

sensitive and acne prone skin

WATER RESISTANT (80 MINUTES)

1.7 FL OZ (50 mL)

Neutrogena_01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/10/2023

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: 11/10/2023

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/10/2023

Active Ingredients

Purpose

Avobenzone (3%)

Sunscreen

Homosalate (13.5%)

Sunscreen

Octisalate (5%)

Sunscreen

Octocrylene (10%)

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 11/10/2023

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 ifrash 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: 11/10/2023

Directions

▪ apply liberally 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: 11/10/2023

Other Information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/10/2023

Inactive Ingredients

Water, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Dimethicone, Camellia Sinensis Leaf Extract, Aluminum Starch Octenylsuccinate, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Bisabolol, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Chlorphenesin, Styrene/Acrylates Copolymer, Menthyl Lactate, Tocopheryl

Acetate, Disodium EDTA, Trideceth-6, Butylene Glycol, Sodium Hydroxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/10/2023

Questions?

Call toll-free800-299-4786 or215-273-8755 (collect) or visit www.neutrogena.com

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Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60 - FDA Drug Approval Details