AVEENO ACTIVE NATURALS HYDROSPORT SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

Aveeno Active Naturals Hydrosport Sunscreen Broad spectrum by

Drug Labeling and Warnings

Aveeno Active Naturals Hydrosport Sunscreen Broad spectrum by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients

Avobenzone 3%
Homosalate 8%
Octisalate 4%
Octocrylene 8%
Oxybenzone 5%

Purpose

Sunscreen

Uses

• 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

Questions?

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

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Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 141.5 g Can Label

Aveeno®
ACTIVE NATURALS®

hydrosport™
wet skin spray
sunscreen

BROAD
SPECTRUM
SPF 30

with natural
lotus complex

oil free

sweat + water
resistant (80 min)

DERMATOLOGIST
RECOMMENDED

NET WT. 5 OZ. (141.5 g)

INGREDIENTS AND APPEARANCE

AVEENO ACTIVE NATURALS HYDROSPORT SUNSCREEN BROAD SPECTRUM   SPF30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0174
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	80 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	40 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethyl Ether (UNII: AM13FS69BX)
ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)
Dimethicone (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Glycerin (UNII: PDC6A3C0OX)
Ascorbyl Palmitate (UNII: QN83US2B0N)
NYMPHAEA CAERULEA FLOWER (UNII: S9560USZ74)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0174-5	141.5 g in 1 CAN; Type 0: Not a Combination Product	05/24/2012	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/24/2012	06/29/2020

Labeler - Johnson & Johnson Consumer Inc. (002347102)