Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 — v9

Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30

9 Views

Version

v9

Effective date

September 26, 2025

Original packager

Yes

Sections captured

15

Identifiers

Document ID
3ed50540-1456-782e-e063-6394a90a1269
Set ID
b10a7794-7e4f-412b-9eb2-773107ecb7fc
Application numbers
M020
Product NDCs
69968-0101
Package NDCs
69968-0101-6, 69968-0101-8
Original packager NDCs
—

Names & Manufacturers

Brand names
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30
Generic names
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE
Manufacturer names
Kenvue Brands LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
4X49Y0596W, 5A68WGF6WM, 95OOS7VE0Y, G63QQF2NOX, V06SV4M95S
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients Avobenzone 3% Homosalate 8% Octisalate 4% Octocrylene 2% Oxybenzone 5%
Do Not Use (1)

Sequence 1

Do not use on damaged or broken skin
Dosage And Administration (1)

Sequence 1

Directions spray liberally and spread evenly by hand 15 minutes before sun exposure apply to all skin exposed to the sun 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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients alcohol denat., isobutane, dimethicone, acrylates/octylacrylamide copolymer, trisiloxane, diethylhexyl 2,6 naphthalate, tocopheryl acetate, fragrance
Indications And Usage (1)

Sequence 1

Uses helps prevent sunburn Sunscreen If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - 240 g Can Label FAMILY SIZE 20% MORE Neutrogena ® Beach Defense ® water + sun protection SUNSCREEN SPRAY Broad Spectrum SPF30 30 helioplex ® broad spectrum uva-uvb water resistant (80 minutes) #1 DERMATOLOGIST RECOMMENDED SUNCARE NET WT. 8.5 OZ. (240g) PRINCIPAL DISPLAY PANEL - 240 g Can Label
Purpose (1)

Sequence 1

Purpose Sunscreen
Questions (1)

Sequence 1

Questions? Call toll-free 800-299-4786 or 215-273-8755 (collect) www.neutrogena.com
Spl Product Data Elements (1)

Sequence 1

Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone HOMOSALATE HOMOSALATE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) ALCOHOL ISOBUTANE DIMETHICONE TRISILOXANE DIETHYLHEXYL 2,6-NAPHTHALATE .ALPHA.-TOCOPHEROL ACETATE
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558
Stop Use (1)

Sequence 1

Stop use and ask a doctor if rash occurs
Storage And Handling (1)

Sequence 1

Other information protect this product from excessive heat and direct sun may stain some fabrics
Warnings (1)

Sequence 1

Warnings For external use only Do not use on damaged or broken skin When using this product keep away from face to avoid breathing it 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. Caution: 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.
When Using (1)

Sequence 1

When using this product keep away from face to avoid breathing it keep out of eyes. Rinse with water to remove

OpenFDA raw payload

{'application_number': ['M020'],
 'brand_name': ['Neutrogena Beach Defense Water Plus Sun Protection Sunscreen '
                'Broad Spectrum SPF30'],
 'generic_name': ['AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND '
                  'OXYBENZONE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Kenvue Brands LLC'],
 'package_ndc': ['69968-0101-8', '69968-0101-6'],
 'product_ndc': ['69968-0101'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3ed50540-1456-782e-e063-6394a90a1269'],
 'spl_set_id': ['b10a7794-7e4f-412b-9eb2-773107ecb7fc'],
 'substance_name': ['AVOBENZONE',
                    'HOMOSALATE',
                    'OCTISALATE',
                    'OCTOCRYLENE',
                    'OXYBENZONE'],
 'unii': ['G63QQF2NOX', 'V06SV4M95S', '4X49Y0596W', '5A68WGF6WM', '95OOS7VE0Y']}