Otc Actives
Active Ingredients Purpose
Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0% Sunscreen
Roc Multi Correxion Revive And Glow Moisturizer Spf 30 Lotion
FDA Label NDC 73496-013
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 Multi Correxion Revive And Glow Moisturizer Spf 30 (NDC 73496-013). 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 otc actives, uses, warnings, keep out of reach of children, indications and usage, 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
Uses
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
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.
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.
Indications And Usage
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.
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.
Other Information
Other information Protect this product from excessive heat and direct sun • May stain some fabrics.
Inactive Ingredients
Water, Propanediol, Dimethicone, Alcohol Denat., C12-15 Alkyl Benzoate, Glycerin, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Diethylhexyl 2,6-Naphthalate, 3-O-Ethyl Ascorbic Acid, Butylene Glycol, Citrullus Lanatus (Watermelon) Fruit Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Pyrus Malus (Apple) Fruit Extract, Cistus Monspeliensis Flower/Leaf/Stem Extract, Lens Esculenta (Lentil) Fruit Extract, Sodium PCA, Sodium Lactate, Nonapeptide-1, Lecithin, Polygonum Aviculare Extract, Troxerutin, Laureth-1 Phosphate, Sodium Polyacrylate, Sclerotium Gum, Pullulan, Maltodextrin, Xanthan Gum, Aminomethyl Propanol, Sodium Phosphate, Caprylyl Glycol, Disodium Phosphate, 1,2-Hexanediol, Caprylhydroxamic Acid, Fragrance.
Questions Or Comments?
Questions or Comments?
Call toll free 1-800-RoC-1964 (1-800-762-1964).
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