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Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70

Neutrogena Beach Defense water + sun protection sunscreen lotion BROAD SPECTRUM SPF 70

Approved
Approval ID

1d3218e6-8687-4a94-8bf7-3a867920cd1c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 8, 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, and Oxybenzone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69968-0560
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 8, 2025
FDA Product Classification

INGREDIENTS (26)

BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERInactive
Code: V5RS026Q0H
Classification: IACT
TRISILOXANEInactive
Code: 9G1ZW13R0G
Classification: IACT
BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
POTASSIUM CETYL PHOSPHATEInactive
Code: 03KCY6P7UT
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIETHYLHEXYL 2,6-NAPHTHALATEInactive
Code: I0DQJ7YGXM
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ETHYLHEXYL STEARATEInactive
Code: EG3PA2K3K5
Classification: IACT
BEHENYL ALCOHOLInactive
Code: 9G1OE216XY
Classification: IACT
TRIDECETH-6Inactive
Code: 3T5PCR2H0C
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 100 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 45 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
OXYBENZONEActive
Quantity: 40 mg in 1 mL
Code: 95OOS7VE0Y
Classification: ACTIB
DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive
Code: 21AS8B1BSS
Classification: IACT
CETYL DIMETHICONE 25Inactive
Code: U4AS1BW4ZB
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/14/2019

PRINCIPAL DISPLAY PANEL - 198 mL Bottle Label

Neutrogena ®

#1 DERMATOLOGIST RECOMMENDED BRAND

Beach
Defense**®******
water + sun
protection

sunscreen lotion
BROAD SPECTRUM SPF 70

70

helioplex**®******
broad spectrum uva•uvb

water resistant (80 minutes)

6.7 FL OZ (198 mL)

PRINCIPAL DISPLAY PANEL - 198 mL Bottle Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/14/2019

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: 5/14/2019

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/14/2019

Active ingredients

Purpose

Avobenzone 3%

Sunscreen

Homosalate 10%

Sunscreen

Octisalate 5%

Sunscreen

Octocrylene 4.5%

Sunscreen

Oxybenzone 4%

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 5/14/2019

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: 5/14/2019

Directions

For Sunscreen Use:

  • apply generously 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: 5/14/2019

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/14/2019

Inactive ingredients

Water, Styrene/Acrylates Copolymer, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Silica, Diethylhexyl 2,6-Naphthalate, Dimethicone/PEG-10/15 Crosspolymer, Trisiloxane, Cetyl Dimethicone, Beeswax, Ethylhexylglycerin, Sodium Polyacrylate, Xanthan Gum, Ethylhexyl Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Trideceth-6, Disodium EDTA, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Glycol, Chlorphenesin, Fragrance

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/14/2019

Questions or Comments?

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

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Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70 - FDA Drug Approval Details