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Neutrogena Hydro Boost Hyaluronic Acid Moisturizer with Sunscreen Broad Spectrum SPF 50

Neutrogena HYDRO BOOST HYALURONIC ACID MOISTURIZER with Sunscreen Broad Spectrum SPF 50

Approved
Approval ID

ea876490-979b-401c-a6bf-35649e7deda0

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 Code69968-0702
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 (26)

HYALURONIC ACIDInactive
Code: S270N0TRQY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CAPRYLYL TRISILOXANEInactive
Code: Q95M2P1KJL
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
POLYURETHANE-62Inactive
Code: TBK645J3J8
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERInactive
Code: V5RS026Q0H
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
MENTHYL LACTATE, (-)-Inactive
Code: 2BF9E65L7I
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
TRIDECETH-6Inactive
Code: 3T5PCR2H0C
Classification: IACT
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONEInactive
Code: BO24ID7E9U
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 150 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 100 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/8/2025

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

Neutrogena**®**

DERMATOLOGIST

RECOMMENDED BRAND

New

SPF


** 50**

HYDRO


** BOOST**


** HYALURONIC ACID**


** MOISTURIZER**


** with Sunscreen**


** Broad Spectrum SPF 50**


** Fragrance Free**

all day quenching


** hydration for soft,**


** supple skin**

1.7 FL OZ (50mL)

Neutrogena_1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/13/2021

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

WARNINGS SECTION

LOINC: 34071-1Updated: 5/13/2021

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 4/8/2025

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/13/2021

Active ingredients

Purpose

Avobenzone 3%

Sunscreen

Homosalate 15%

Sunscreen

Octisalate 5%

Sunscreen

Octocrylene 10%.

Sunscreen

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/13/2021

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: 5/13/2021

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/13/2021

Inactive ingredients

Water, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Caprylyl Methicone, Caprylic/Capric Triglyceride, Aluminum Starch Octenylsuccinate, Dimethicone, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Styrene/Acrylates Copolymer, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Chlorphenesin, Menthyl Lactate, Tocopheryl Acetate, Disodium EDTA, Trideceth-6, Hydrolyzed Hyaluronic Acid, Hydroxymethoxyphenyl Decanone, Sodium Hydroxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/13/2021

Questions?

Call toll-free800-582-4048 or 215-273-8755 (collect) or visit www.neutrogena.com

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Neutrogena Hydro Boost Hyaluronic Acid Moisturizer with Sunscreen Broad Spectrum SPF 50 - FDA Drug Approval Details