Active Ingredients
Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%
Roc Hydration Plus Spf 30 Lotion
FDA Label NDC 73496-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roc Skincare for the product Roc Hydration Plus Spf 30 (NDC 73496-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions for sunscreen use:, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
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.
Questions Or Comments?
Call toll free 1-800-RoC-1964 (1-800-762-1964)
Package Label.Principal Display Panel
Tube (Hydrationplusspf30tube)
Carton (Hydrationplusspf30tubecarton)
Glass (Hydrationplusspf30glass)
Carton (Hydrationplusspf30glasscarton.jpg)
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