roc hydration plus spf 30 lotion

roc hydration plus spf 30 lotion
SPL v1
SPL
SPL Set ID 45a3e250-8195-344d-e063-6294a90ae681
Route
topical
Published
Effective Date 2025-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (4.5 mg) homosalate (5.5 mg) avobenzone (2 mg) octocrylene (4 mg)
Inactive Ingredients
hyaluronate sodium aminomethylpropanol caprylyl trisiloxane pentylene glycol octyldodecanol propanediol hyaluronic acid ammonium acryloyldimethyltaurate/vp copolymer dibutyl ethylhexanoyl glutamide water dimethicone potassium cetyl phosphate biosaccharide gum-4 edetate disodium glycerin dibutyl lauroyl glutamide caprylhydroxamic acid 1,2-hexanediol capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) jasminum sambac flower carbomer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-08-27 Until 2028-03-31
Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Medication Information

Warnings and Precautions

For external use only

Do not useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove. Stop use and ask a doctorif rash occurs.

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

Other Information
  • Protect this product from excessive heat and direct sun
Inactive Ingredients

Water/Aqua/Eau, Pentylene Glycol, Dimethicone, Octyldodecanol, Caprylyl Methicone, Propanediol, Potassium Cetyl Phosphate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hyaluronic Acid, 1,2-Hexanediol, Hydrolyzed Sodium Hyaluronate, Biosaccharide Gum-4, Jasminum Sambac (Jasmine) Leaf Cell Extract, Glycerin, Dibutyl Lauroyl Glutamide, Carbomer, Aminomethyl Propanol, Dibutyl Ethylhexanoyl Glutamide, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylhydroxamic Acid, Disodium EDTA, Fragrance/Parfum.

Description

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Section 50565-1

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

Section 51945-4

Active Ingredients

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Questions Or Comments?

Call toll free 1-800-RoC-1964 (1-800-762-1964)

Directions for Sunscreen Use:
  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Do not useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove. Stop use and ask a doctorif rash occurs.

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

Other Information (Other information)
  • Protect this product from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Pentylene Glycol, Dimethicone, Octyldodecanol, Caprylyl Methicone, Propanediol, Potassium Cetyl Phosphate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hyaluronic Acid, 1,2-Hexanediol, Hydrolyzed Sodium Hyaluronate, Biosaccharide Gum-4, Jasminum Sambac (Jasmine) Leaf Cell Extract, Glycerin, Dibutyl Lauroyl Glutamide, Carbomer, Aminomethyl Propanol, Dibutyl Ethylhexanoyl Glutamide, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylhydroxamic Acid, Disodium EDTA, Fragrance/Parfum.

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 51945-4 (51945-4)

Active Ingredients

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Questions Or Comments? (Questions or Comments?)

Call toll free 1-800-RoC-1964 (1-800-762-1964)

Directions for Sunscreen Use: (Directions For Sunscreen Use:)
  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:36.779542 · Updated: 2026-03-14T23:11:14.961491