NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, and octo

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX), Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S), Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W), Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)
Available from:
Johnson & Johnson Consumer Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- helps prevent sunburn - 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
Authorization status:
OTC monograph not final
Authorization number:
69968-0561-7, 69968-0561-9

NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN

BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, and octocrylene spray

Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Neutrogena

Beach Defense

water + sun protection sunscreen spray BROAD SPECTRUM

SPF30

Drug Facts

Active ingredients

Purpose

Avobenzone 3%

Sunscreen

Homosalate 8%

Sunscreen

Octisalate 5%

Sunscreen

Octocrylene 8%

Sunscreen

Us es

helps prevent sunburn

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

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.

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

Other information

protect this product from excessive heat and direct sun

may stain some fabrics

Inactive ingredients

Alcohol Denat., Isobutane, Dicaprylyl Carbonate, Polyester-7, Acrylates/Octylacrylamide Copolymer,

Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate

Questions or Comments?

Call toll-free 800-299-4786 or 215-273-8755 (collect). www.neutrogena.com

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 240 g Can Label

VALUE SIZE

30% MORE

Neutrogena

# 1 DERMATOLOGIST RECOMMENDED BRAND

Beach

Defens e

water + sun

protection

sunscreen spray

BROAD SPECTRUM SPF 30

30

helioplex

broad spectrum uvauvb

oxybenzone free

water resistant (80 minutes)

NET WT. 8.5 OZ. (240 g)

®

®

NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION

Johnson & Johnson Consumer Inc.

SUNSCREEN BROAD SPECTRUM SPF 30

avobenzone, homosalate, octisalate, and octocrylene spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 6 8 -0 56 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Avo benzo ne (UNII: G6 3QQF2NOX) (Avo benzo ne - UNII:G6 3QQF2NOX)

Avo be nz o ne

30 mg in 1 g

Ho mo sa la te (UNII: V0 6 SV4M9 5S) (Ho mo salate - UNII:V0 6 SV4M9 5S)

Ho mo sa la te

8 0 mg in 1 g

O ctisa la te (UNII: 4X49 Y0 59 6 W) (Octisalate - UNII:4X49 Y0 59 6 W)

O c tisa la te

50 mg in 1 g

O cto crylene (UNII: 5A6 8 WGF6 WM) (Octo crylene - UNII:5A6 8 WGF6 WM)

O c to c ryle ne

8 0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Alco ho l (UNII: 3K9 9 58 V9 0 M)

Iso buta ne (UNII: BXR49 TP6 11)

Dica prylyl Ca rbo na te (UNII: 6 0 9 A3V1SUA)

Po lyester-7 (UNII: 0 8 416 9 8 D2F)

Neo pentyl Glyco l Dihepta no a te (UNII: 5LKW3C543X)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

ACRYLATE/ISO BUTYL METHACRYLATE/N-TERT-O CTYLACRYLAMIDE CO PO LYMER ( 7 50 0 0 MW) (UNII:

JU3XHR8 VWK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 9 6 8 -0 56 1-9

240 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 19

2

NDC:6 9 9 6 8 -0 56 1-7

18 4 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

0 9 /0 1/20 19

Labeler -

Johnson & Johnson Consumer Inc. (002347102)

Revised: 7/2019

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