AVEENO PROTECT PLUS HYDRATE SUNSCREEN BROAD SPECTRUM BODY SPF 30- avobenzone, homosalate, octisalate, and octocrylene lotion

Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30 by

Drug Labeling and Warnings

Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30 by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 1.5%	Sunscreen
Homosalate 5%	Sunscreen
Octisalate 4%	Sunscreen
Octocrylene 6%	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 liberally 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, Glycerin, Diisopropyl Adipate, Alcohol Denat., Caprylyl Methicone, Dimethicone, Silica, Dicaprylyl Carbonate, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Polyurethane-62, Hydroxyacetophenone, Pentylene Glycol, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Phenoxyethanol, Chlorphenesin, Dimethicone Crosspolymer, Fragrance, Disodium EDTA, Trideceth-6, Avena Sativa (Oat) Kernel Extract, Sodium Hydroxide

Questions?

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

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Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

DERMATOLOGIST

RECOMMENDED

Aveeno ®

PROTECT+

HYDRATE

sunscreen

BROAD-SPECTRUM

UVA+UVB PROTECTION

all-day hydration

with prebiotic oat

oxybenzone free

sweat + water resistant

(80 min)

SPF

30

3.0 FL OZ (88mL)

INGREDIENTS AND APPEARANCE

AVEENO PROTECT PLUS HYDRATE SUNSCREEN BROAD SPECTRUM BODY SPF 30 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0667
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	15 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYURETHANE-62 (UNII: TBK645J3J8)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALCOHOL (UNII: 3K9958V90M)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
OAT (UNII: Z6J799EAJK)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0667-3	80 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2020	01/23/2021
2	NDC: 69968-0667-1	88 mL in 1 TUBE; 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 Drug	M020	10/01/2020

Labeler - Kenvue Brands LLC (118772437)