MedPath

Neutrogena Beach Defense Kids Sunscreen SPF 60 Plus

Neutrogena Beach Defense Kids Sunscreen Stick SPF 60 Plus

Approved
Approval ID

fea50c84-0567-8547-e053-6394a90aafb7

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 Code69968-0816
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 (18)

OCTYLDODECYL NEOPENTANOATEInactive
Code: X8725R883T
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
ISOHEXADECANEInactive
Code: 918X1OUF1E
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
DIETHYLHEXYL 2,6-NAPHTHALATEInactive
Code: I0DQJ7YGXM
Classification: IACT
SYNTHETIC BEESWAXInactive
Code: 08MNR5YE2R
Classification: IACT
NEOPENTYL GLYCOL DIISOSTEARATEInactive
Code: 4M6OQ34JWW
Classification: IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEInactive
Code: U68ZV6W62C
Classification: IACT
HOMOSALATEActive
Quantity: 150 mg in 1 g
Code: V06SV4M95S
Classification: ACTIB
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
OCTISALATEActive
Quantity: 50 mg in 1 g
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 100 mg in 1 g
Code: 5A68WGF6WM
Classification: ACTIB
AVOBENZONEActive
Quantity: 30 mg in 1 g
Code: G63QQF2NOX
Classification: ACTIB
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERInactive
Code: V5RS026Q0H
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/21/2023

PRINCIPAL DISPLAY PANEL - 42 g Canister

Neutrogena®

DERMATOLOGIST RECOMMENDED BRAND

Beach Defense®

kids

water + sun protection

sunscreen stick

BROAD SPECTRUM SPF 60+

60+

with

multi-

vitamins

water resistant (80 minutes)

NET WT. 1.5 OZ (42 g)

Neutrogena_01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/21/2023

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: 10/14/2022

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/26/2023

Active ingredients

Avobenzone (3%),

Homosalate (15%),

Octisalate (5%),

Octocrylene (10%)

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 6/21/2023

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 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: 6/21/2023

Directions

▪ apply liberally and evenly 15 minutes before sun exposure

▪ ensure complete coverage to the area above the lip, nose and tops of ears

▪ 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

▪ After use, twist stick down prior to capping to ensure complete closure.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/21/2023

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/21/2023

Inactive ingredients

Neopentyl Glycol Diethylhexanoate, Octyldodecyl Neopentanoate, Synthetic Wax, Isohexadecane, Butyloctyl Salicylate, Ozokerite, Paraffin, Synthetic Beeswax, C12-15 Alkyl Benzoate, VP/Eicosene Copolymer, Neopentyl Glycol Diisostearate, Dimethicone, Diethylhexyl 2,6-Naphthalate, Tocopheryl Acetate, Ascorbyl Palmitate, Styrene/Acrylates Copolymer, Fragrance

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/21/2023

Questions?

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

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Neutrogena Beach Defense Kids Sunscreen SPF 60 Plus - FDA Drug Approval Details