NEUTROGENA MEN TRIPLE PROTECT FACE WITH SUNSCREEN BROAD SPECTRUM SPF 20- avobenzone, homosalate, octisalate, octocrylene, and ox

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:
69968-0520-1

NEUTROGENA MEN TRIPLE PROTECT FACE WITH SUNSCREEN BROAD SPECTRUM

SPF 20- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

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

MEN TRIPLE PROTECT Face Lotion with sunscreen Broad Spectrum SPF 20

Drug Facts

Active ingredients

Purpose

Avobenzone 3%

Sunscreen

Homosalate 12%

Sunscreen

Octisalate 5%

Sunscreen

Octocrylene 1.7%

Sunscreen

Oxybenzone 3%

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.

Directions

Apply liberally and evenly to freshly shaven face and neck every morning.

For Sunscreen Use:

apply liberally 15 minutes before sun exposure

reapply: at least every 2 hours

use a water resistant sunscreen if swimming or sweating

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

Water, Octyldodecyl Neopentanoate, Glycerin, Glycine Soja (Soybean) Seed Extract, Emulsifying Wax,

Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Silica, Phenoxyethanol, Panthenol, Tocopheryl

Acetate, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol,

Fragrance, Bisabolol, Camellia Sinensis Leaf Extract, Methylparaben, Disodium EDTA, Allantoin,

Butylene Glycol, Sodium Hydroxide

Ques tions ?

Call toll-free 866-638-4636 or 215-273-8755 (collect). www.neutrogenamen.com

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

Neutrogena

MEN

TRIPLE PROTECT

Face Lotion

with

sunscreen

Broad Spectrum

SPF 20

Soothes razor irritation

Relieves dry skin

Helps fight signs of aging

1.7 FL OZ (50mL)

®

NEUTROGENA MEN TRIPLE PROTECT FACE WITH SUNSCREEN BROAD

SPECTRUM SPF 20

avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 6 8 -0 520

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 mL

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

Ho mo sa la te

120 mg in 1 mL

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 mL

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

O c to c ryle ne

17 mg in 1 mL

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

O xybe nz o ne

30 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

O ctyldo decyl Neo penta no a te (UNII: X8 725R8 8 3T)

Glycerin (UNII: PDC6 A3C0 OX)

So ybea n (UNII: L7HT8 F1ZOD)

Glyceryl Mo no stea ra te (UNII: 230 OU9 XXE4)

PEG-10 0 Stea ra te (UNII: YD0 1N19 9 9 R)

Dimethico ne (UNII: 9 2RU3N3Y1O)

Silico n Dio xide (UNII: ETJ7Z6 XBU4)

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

Pa ntheno l (UNII: WV9 CM0 O6 7Z)

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

Ethylhexylg lycerin (UNII: 147D247K3P)

Ca rbo mer Interpo lymer Type A ( Allyl Sucro se Cro sslinked) (UNII: 59 TL3WG5CO)

Ca prylyl Glyco l (UNII: 0 0 YIU5438 U)

Levo meno l (UNII: 24WE0 3BX2T)

Green Tea Lea f (UNII: W2ZU1RY8 B0 )

Methylpa ra ben (UNII: A2I8 C7HI9 T)

Edeta te Diso dium Anhydro us (UNII: 8 NLQ36 F6 MM)

Alla nto in (UNII: 344S277G0 Z)

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

So dium Hydro xide (UNII: 55X0 4QC32I)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 9 6 8 -0 520 -1

1 in 1 CARTON

0 5/17/20 19

1

50 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Johnson & Johnson Consumer Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 5/17/20 19

Labeler -

Johnson & Johnson Consumer Inc. (002347102)

Revised: 6/2020

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