Package Label.Principal Display Panel
PACKAGE LABEL PRINCIPAL DISPLAY PANEL
Roc Multi Correxion 5 In 1 Daily Moisturizer Sunscreen Broad Spectrum Spf30
FDA Label NDC 73496-002
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 5 In 1 Daily Moisturizer Sunscreen Broad Spectrum Spf30 (NDC 73496-002). 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 package label.principal display panel, otc - purpose, otc - keep out of reach of children, uses, warnings, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Active ingredientsPurposeAvobenzone (2%)SunscreenHomosalate (4%)SunscreenOctisalate (4%)SunscreenOctocrylene (2%)Sunscreen
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
Uses
Helps prevent sunburnif 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
Directions
For sunscreen use:apply generously and evenly15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 sunglasseschildren under 6 months of age: Ask a doctor
Inactive Ingredients
Water, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ascorbyl Glucoside, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Methyl Methacrylate Crosspolymer, Hexylresorcinol, Steareth-21, Behenyl Alcohol, Dimethicone Crosspolymer, Phenoxyethanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Hydroxide, Caprylyl Glycol, Sclerotium Gum, Fragrance, Mica, Titanium Dioxide, Methylparaben, Disodium EDTA, Ethylparaben, Propylparaben
Questions?
Call 1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755, or visit ww.rocskincare.com
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