AVEENO ACTIVE NATURALS DAILY MOISTURIZING BROAD SPECTRUM SPF15- avobenzone, octisalate, octocrylene, and oxybenzone lotion

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

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Active ingredient:
Avobenzone 3% Homosalate 5% Octisalate 1.7% Octocrylene 3%
Available from:
Johnson & Johnson Consumer Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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:
69968-0125-1

AVEENO ACTIVE NATURALS DAILY MOISTURIZING BROAD SPECTRUM SPF15-

avobenzone, 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.

----------

Aveeno

ACTIVE NATURALS Daily Moisturizing LOTION with sunscreen

BROAD SPECTRUM SPF 15

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 1.7%

Octocrylene 3%

Purpos e

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 generously and evenly 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 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

Water, Glycerin, Distearyldimonium Chloride, C12-15 Alkyl Benzoate, Cetyl Alcohol, Diethylhexyl

2,6-Naphthalate, Dimethicone, Avena Sativa (Oat) Kernel Flour, Methylparaben, Steareth-21, Disodium

EDTA, Benzalkonium Chloride

Ques tions ?

1-866-AVEENO; Outside US, dial collect 215-273-8755 or visit www.aveeno.com

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

dermatologis t

recommended

Aveeno

ACTIVE NATURALS

Daily Moisturizing

LOTION

with

s uns creen

BROAD SPECTRUM

SPF 15

clinically shown to

moisturize for 24 hours

non-greas y

with

natural colloidal oatmeal

12 fl. oz. (354 mL)

®

®

AVEENO ACTIVE NATURALS DAILY MOISTURIZING BROAD SPECTRUM

SPF15

avobenzone, octisalate, octocrylene, and oxybenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 6 8 -0 125

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

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

Johnson & Johnson Consumer Inc.

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Glycerin (UNII: PDC6 A3C0 OX)

Distea ryldimo nium Chlo ride (UNII: OM9 573ZX3X)

Alkyl ( C12 -15) Benzo a te (UNII: A9 EJ3J6 1HQ)

Cetyl Alco ho l (UNII: 9 36 JST6 JCN)

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

Dimethico ne (UNII: 9 2RU3N3Y1O)

O a tmea l (UNII: 8 PI54V6 6 3Y)

Methylpa ra ben (UNII: A2I8 C7HI9 T)

Stea reth-2 1 (UNII: 53J3F32P58 )

Edeta te Diso dium (UNII: 7FLD9 1C8 6 K)

Benza lko nium Chlo ride (UNII: F5UM2KM3W7)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 9 6 8 -0 125-1 354 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/0 1/20 0 7

12/0 6 /20 20

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

12/0 1/20 0 7

12/0 6 /20 20

Labeler -

Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2019

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