aveeno ®

aveeno ®
SPL v11
SPL
SPL Set ID 615c5349-7fff-4145-9d65-1687247163be
Route
topical
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (135 mg) octisalate (50 mg) octocrylene (100 mg)
Inactive Ingredients
polyurethane-62 2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw) alcohol water butyloctyl salicylate glycerin silicon dioxide caprylyl trisiloxane aluminum starch octenylsuccinate dimethicone phenoxyethanol pentylene glycol butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer glyceryl monostearate chlorphenesin edetate disodium anhydrous trideceth-6 oat sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2020-10-01 Until 2023-12-15
Purpose

Sunscreen

Description

Drug Facts

Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

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, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Caprylyl Methicone, Aluminum Starch Octenylsuccinate, Dimethicone, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Chlorphenesin, Styrene/Acrylates Copolymer, Fragrance, Disodium EDTA, Trideceth-6, Avena Sativa (Oat) Kernel Extract, Sodium Hydroxide

Description

Drug Facts

Questions?

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50570-1
  • Do not use on damaged or broken skin
Active Ingredients

Avobenzone 3%, Homosalate 13.5%, Octisalate 5%, Octocrylene 10%

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Principal Display Panel 88 Ml Bottle Label

DERMATOLOGIST

RECOMMENDED

Aveeno ®

PROTECT+

HYDRATE

sunscreen

BROAD-SPECTRUM

UVA + UVB PROTECTION

all-day hydration

with prebiotic oat

oxybenzone free

sweat + water resistant

(80min)

SPF

60

3.0 FL OZ (88 mL)

Structured Label Content

Warnings

For external use only

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
Purpose

Sunscreen

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 (Other information)
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Inactive Ingredients (Inactive ingredients)

Water, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Caprylyl Methicone, Aluminum Starch Octenylsuccinate, Dimethicone, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Chlorphenesin, Styrene/Acrylates Copolymer, 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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 13.5%, Octisalate 5%, Octocrylene 10%

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Principal Display Panel 88 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label)

DERMATOLOGIST

RECOMMENDED

Aveeno ®

PROTECT+

HYDRATE

sunscreen

BROAD-SPECTRUM

UVA + UVB PROTECTION

all-day hydration

with prebiotic oat

oxybenzone free

sweat + water resistant

(80min)

SPF

60

3.0 FL OZ (88 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:18.955945 · Updated: 2026-03-14T23:10:38.535907