NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone

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), Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)
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:
69968-0021-5

NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN BROAD SPECTRUM SPF30-

avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, 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

Ultimate Sheer BODY MIST SUNSCREEN Broad Spectrum SPF 30

Drug Facts

Active ingredients

Purpose

Avobenzone 3%

Sunscreen

Homosalate 8%

Sunscreen

Octisalate 4%

Sunscreen

Octocrylene 2.35%

Sunscreen

Oxybenzone 5%

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

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 contents can be harmful or fatal

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 value of SPF 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, dimethicone, diethylhexyl 2,6 – naphthalate, trisiloxane, PPG-5-ceteth-20,

acrylates/ octylacrylamide copolymer, cyclopentasiloxane, fragrance, acrylates/dimethicone

copolymer, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, tocopherol

Ques tions ?

800-299-4786; Outside US, dial collect 215-273-8755

Distributed by: JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 141 g Can Label

NewFullReach™

design

even reaches your back

Neutrogena

Ultra Sheer

BODY MIST

SUNSCREEN

Broad Spectrum SPF 30

30

helioplex

broad spectrum uva-uvb

WEIGHTLESS,

CLEAN FEEL

non-greasy

water resistant (80 minutes)

# 1 DERMATOLOGIST

RECOMMENDED SUNCARE

NET WT. 5.0 OZ.

(141g)

®

®

®

NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN BROAD SPECTRUM

SPF30

avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

Johnson & Johnson Consumer Inc.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 6 8 -0 0 21

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

40 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

23.5 mg in 1 g

O xybenzo ne (UNII: 9 5OOS7VE0 Y) (Oxybenzo ne - UNII:9 5OOS7VE0 Y)

O xybe nz o ne

50 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

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

JU3XHR8 VWK)

BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CRO SSPO LYMER (UNII:

V5RS0 26 Q0 H)

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

Asco rbyl Pa lmita te (UNII: QN8 3US2B0 N)

Cyclo methico ne 5 (UNII: 0 THT5PCI0 R)

Diethylhexyl 2 ,6 -Na phtha la te (UNII: I0 DQJ7YGXM)

Dimethico ne (UNII: 9 2RU3N3Y1O)

Iso buta ne (UNII: BXR49 TP6 11)

PPG-5-Ceteth-2 0 (UNII: 4AAN25P8 P4)

Vita min A Pa lmita te (UNII: 1D1K0 N0 VVC)

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

Trisilo xa ne (UNII: 9 G1ZW13R0 G)

To co phero l (UNII: R0 ZB2556 P8 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 9 6 8 -0 0 21-5

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

0 2/0 5/20 0 7

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 2/0 5/20 0 7

Labeler -

Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2020

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