NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN BROAD SPECTRUM SPF 45- avobenzone, homosalate, octisalate, and octocrylene spray

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:
69968-0579-5, 69968-0579-8

NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN BROAD SPECTRUM SPF 45-

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

Ultra Sheer

body mist sunscreen BROAD SPECTRUM SPF 45

Drug Facts

Active ingredients

Purpose

Avobenzone 3%

Sunscreen

Homosalate 10%

Sunscreen

Octisalate 5%

Sunscreen

Octocrylene 10%

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

Ques tions ?

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 - 226 g Can Label

VALUE SIZE

60% MORE

Neutrogena

# 1 DERMATOLOGIST RECOMMENDED BRAND

Ultra Sheer

body mist

s uns creen

BROAD SPECTRUM SPF 45

45

helioplex

broad spectrum uvauvb

weightless clean feel

oxybenzone free

water resistant (80 minutes)

NET WT. 8.0 OZ. (226 g)

®

NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN BROAD SPECTRUM

SPF 45

Johnson & Johnson Consumer Inc.

avobenzone, homosalate, octisalate, and octocrylene spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 6 8 -0 579

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

10 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

10 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)

Acryla te/Iso butyl Metha cryla te/N-Tert-O ctyla cryla mide Co po lymer ( 7 50 0 0 MW) (UNII: JU3XHR8 VWK)

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

.Alpha .-To co phero l Aceta te (UNII: 9 E8 X8 0 D2L0 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 9 6 8 -0 579 -8

226 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 -0 579 -5

141 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: 11/2019

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