MedPath

Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30

Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30

Approved
Approval ID

1659f2ac-5dbc-553e-e063-6394a90a9a4d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 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 Code69968-0890
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (29)

STEARETH-100Inactive
Code: 4OH5W9UM87
Classification: IACT
ETHYLHEXYL STEARATEInactive
Code: EG3PA2K3K5
Classification: IACT
NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
BHTInactive
Code: 1P9D0Z171K
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
TRIDECETH-6Inactive
Code: 3T5PCR2H0C
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CETYL DIMETHICONE 25Inactive
Code: U4AS1BW4ZB
Classification: IACT
HOMOSALATEActive
Quantity: 80 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 80 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERInactive
Code: V5RS026Q0H
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
MANNANInactive
Code: 91R887N59P
Classification: IACT
CENTELLA ASIATICA TRITERPENOIDSInactive
Code: 4YS74Q4G4J
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
LEVOMENOLInactive
Code: 24WE03BX2T
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
AVOBENZONEActive
Quantity: 25 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
STEARETH-2Inactive
Code: V56DFE46J5
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)Inactive
Code: S7ZA3CCJ4M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/16/2024

PRINCIPAL DISPLAY PANEL - 100 mL Tube

Neutrogena**®**

DERMATOLOGIST RECOMMENDED BRAND

SPF

30

ULTRA

GENTLE

Daily Facial

Moisturizer

Sunscreen

Broad Spectrum SPF 30

Normal to Sensitive Skin

Lightweight, strengthens

skin’s moisture barrier

in 1 use

with CICA

3.4 FL OZ (100 mL)

Neutrogena

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/18/2024

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/18/2024

Purpose

Sunscreen

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 4/18/2024

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/18/2024

Active ingredients

Avobenzone (2.5%), Homosalate (8%), Octisalate (5%), Octocrylene (8%)

WARNINGS SECTION

LOINC: 34071-1Updated: 4/18/2024

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: 4/18/2024

Directions

For sunscreen use: apply generously and evenly 15 minutes before sun exposure

  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating *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: 4/18/2024

Other information

  • protect this product from excessive heat and direct sun
  • may stain some fabrics
  • Do not use if quality seal is broken or missing

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/18/2024

Inactive ingredients

Water, Silica, Cetyl Dimethicone, Styrene/Acrylates Copolymer, C12-15 Alkyl Benzoate, Ethylhexylglycerin, Centella Asiatica Extract, Bisabolol, Caprylyl Glycol, Butylene Glycol, Dimethicone, Steareth-100, Steareth-2, Xanthan Gum, Mannan, Aluminum Starch Octenylsuccinate, Ethylhexyl Stearate, Trideceth-6, Neopentyl Glycol Diheptanoate, Polyester-7, Sodium Polyacrylate, Acrylates/Dimethicone Copolymer, Disodium EDTA, BHT, Phenoxyethanol, Chlorphenesin

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/16/2024

Questions?

800-582-4048; Outside US, dial collect215-273-8755. neutrogena.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30 - FDA Drug Approval Details