AVEENO ACTIVE NATURALS HYDROSPORT SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzo

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

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Active ingredient:
Avobenzone 3% Homosalate 8% Octisalate 4% Octocrylene 8% Oxybenzone 5%
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:
69968-0174-5

AVEENO ACTIVE NATURALS HYDROSPORT 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.

----------

Aveeno

ACTIVE NATURALS hydrosport

sunscreen BROAD SPECTRUM SPF 30

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 8%

Octisalate 4%

Octocrylene 8%

Oxybenzone 5%

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 away from face to avoid breathing it

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 the contents can be harmful or fatal.

Directions

shake well before and frequently during use

spray generously and spread evenly by hand 15 minutes before sun exposure

hold container 4 to 6 inches from the skin to apply. Rub in

do not spray directly into face. Spray on hands 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., Dimethyl Ether, Octyldodecyl Citrate Crosspolymer, Ethyl Methicone,

Acrylates/Octylacrylamide Copolymer, Dimethicone, Fragrance, Acrylates/Dimethicone Copolymer,

Tocopheryl Acetate, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Diethylhexyl 2,6-

Naphthalate, Glycerin, Water, Ascorbyl Palmitate, Nymphaea Coerulea Flower Extract

Ques tions ?

Call 1-866-4Aveeno; Outside US, dial collect 215-273-8755 or visit www.aveeno.com

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 141.5 g Can Label

Aveeno

ACTIVE NATURALS

hydros port™

wet skin spray

s uns creen

BROAD

SPECTRUM

SPF 30

with natural

lotus complex

oil free

sweat + water

resistant (80 min)

DERMATOLOGIST

RECOMMENDED

®

®

NET WT. 5 OZ. (141.5 g)

AVEENO ACTIVE NATURALS HYDROSPORT SUNSCREEN BROAD

SPECTRUM SPF30

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

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 6 8 -0 174

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

Johnson & Johnson Consumer Inc.

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

8 0 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

Dimethyl Ether (UNII: AM13FS6 9 BX)

ETHYL METHICO NE ( 8 MPA.S) (UNII: 3YWG8 XYT8 H)

Dimethico ne (UNII: 9 2RU3N3Y1O)

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

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

Glycerin (UNII: PDC6 A3C0 OX)

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

NYMPHAEA CAERULEA FLO WER (UNII: S9 56 0 USZ74)

Wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 9 6 8 -0 174-5

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

0 5/24/20 12

0 6 /29 /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

0 5/24/20 12

0 6 /29 /20 20

Labeler -

Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2019

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