AVEENO PROTECT PLUS HYDRATE SUNSCREEN BROAD SPECTRUM SPF 70- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Aveeno Protect Plus Hydrate by

Drug Labeling and Warnings

Aveeno Protect Plus Hydrate 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 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

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.

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:
  • 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

Water, Styrene/Acrylates Copolymer, Silica, Dimethicone, Benzyl Alcohol, Glycerin, Ethylhexylglycerin, Glyceryl Stearate, PEG-100 Stearate, Beeswax, Acrylates/Dimethicone Copolymer, Behenyl Alcohol, Phenoxyethanol, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Chlorphenesin, Propylene Glycol, Sodium Hydroxide, Diethylhexyl 2,6-Naphthalate, Disodium EDTA, Fragrance, Avena Sativa (Oat) Kernel Flour, Avena Sativa (Oat) Kernel Extract, Codium Tomentosum Extract, Hydrolyzed Oat Protein, Potassium Palmitoyl Hydrolyzed Oat Protein

Questions?

Call toll-free 1-866-4AVEENO or 215-273-8755 (collect) or visit www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 198 g Tube Label

DERMATOLOGIST
RECOMMENDED
Aveeno®

PROTECT +
HYDRATE

sunscreen

BROAD SPECTRUM SPF 70

with antioxidant oat

all-day hydration

sweat + water resistant
 (80 min)

SPF
70

net wt. 7 OZ. (198 g)

INGREDIENTS AND APPEARANCE

AVEENO PROTECT PLUS HYDRATE   SUNSCREEN BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0393
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	150 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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Dimethicone (UNII: 92RU3N3Y1O)
Benzyl Alcohol (UNII: LKG8494WBH)
Glycerin (UNII: PDC6A3C0OX)
Ethylhexylglycerin (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
YELLOW WAX (UNII: 2ZA36H0S2V)
DOCOSANOL (UNII: 9G1OE216XY)
Phenoxyethanol (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
Chlorphenesin (UNII: I670DAL4SZ)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Hydroxide (UNII: 55X04QC32I)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0393-7	198 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2018
2	NDC: 69968-0393-3	85 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2018

Labeler - Johnson & Johnson Consumer Inc. (002347102)