MedPath

Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 60 Plus

Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 60+

Approved
Approval ID

39710a1a-fe8c-41f2-b60c-db3e99d60a86

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 Code69968-0601
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 (11)

ISOBUTANEInactive
Code: BXR49TP611
Classification: IACT
DICAPRYLYL CARBONATEInactive
Code: 609A3V1SUA
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)Inactive
Code: JU3XHR8VWK
Classification: IACT
NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 g
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 100 mg in 1 g
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 g
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 100 mg in 1 g
Code: 5A68WGF6WM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/25/2022

PRINCIPAL DISPLAY PANEL - 240 g Can Label

VALUE SIZE

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

Beach


** Defense****®**

water + sun


** protection**

sunscreen spray


** BROAD SPECTRUM SPF 60+**

60+

helioplex**®******


** broad spectrum uva•uvb**

oxybenzone free

water resistant (80 minutes)

NET WT. 8.5 OZ. (240 g)

Ntg-001

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2020

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/20/2020

Inactive ingredients

Alcohol Denat., Isobutane, Dicaprylyl Carbonate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/20/2020

Questions or Comments?

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/20/2020

Distributed by:
JOHNSON & JOHNSON
Skillman, NJ 08558

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2020

Active ingredients

Purpose

Avobenzone 3%

Sunscreen

Homosalate 10%

Sunscreen

Octisalate 5%

Sunscreen

Octocrylene 10%

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2020

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.
  • keep away from face to avoid breathing it

*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

*Danger: Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120°F (48°C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2020

Directions

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4-6 inches from the skin to apply. Rub in.
  • do not spray directly into face. Spray on hands and then apply to face. Rub in.
  • do not apply in windy conditions
  • use in a well-ventilated area
  • 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: 8/20/2020

Other information

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

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Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 60 Plus - FDA Drug Approval Details