AVEENO PROTECT PLUS REFRESH SUNSCREEN BROAD SPECTRUM BODY SPF 60- avobenzone, homosalate, octisalate, and octocrylene spray

Aveeno Protect Plus Refresh Sunscreen Broad Spectrum Body SPF 60 by

Drug Labeling and Warnings

Aveeno Protect Plus Refresh Sunscreen Broad Spectrum Body SPF 60 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 (10%), Octisalate (5%), Octocrylene (10%)

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 out of eyes. Rinse with water to remove.
  • keep away from face to avoid breathing it
• 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

Warning: 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

• spray liberally and spread evenly by hand 15 minutes before sun exposure
• 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 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., Isobutane, Dicaprylyl Carbonate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Avena Sativa (Oat) Kernel Oil, Ascorbyl Palmitate

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 141 g Can Label

NEW
WEIGHTLESS
FORMULA

DERMATOLOGIST
RECOMMENDED

Aveeno ®
PROTECT+
REFRESH

sunscreen
BROAD-SPECTRUM
UVA+ UVB PROTECTION

weightless spray
with oat

oxybenzone free
sweat + water resistant
(80min)

SPF
60
NET WT. 5.0 OZ (141g)

INGREDIENTS AND APPEARANCE

AVEENO PROTECT PLUS REFRESH SUNSCREEN BROAD SPECTRUM BODY SPF 60 
avobenzone, homosalate, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0668
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	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
OAT KERNEL OIL (UNII: 3UVP41R77R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0668-5	141 g in 1 CAN; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2020

Labeler - Johnson & Johnson Consumer Inc. (118772437)