Otc - Active Ingredient
Avobenzone 3.0%
Homosalate 10.0%
Octisalate 5.0%
Naturium Dew Glow Tinted Moisturizer Spf50-medium Lotion
FDA Label NDC 59735-921
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pml Nyc, Llc for the product Naturium Dew Glow Tinted Moisturizer Spf50-medium (NDC 59735-921). 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 - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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 signs of aging caused by the sun.
Warnings
For external use only.
Otc - Do Not Use
on damaged or broken skin.
Otc - When Using
keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
if product is 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.
Apply to all skin exposed to the sun.
Use a water-resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 a.m. - 2:00 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 Ingredient
Aqua/Water/Eau, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Sodium Borosilicate, Glycerin, Glyceryl Stearate, Ethylhexyl Methoxycrylene, VP/Eicosene Copolymer, Stearyl Dimethicone, Argania Spinosa Kernel Oil, Tocopheryl Acetate, 1,2-Hexandiol, Niacinamide, Sodium Stearoyl Glutamate, Tocopherol, Cetearyl Olivate, Bisabolol, 3-O-Ethyl Ascorbic Acid, Sodium Hyaluronate, Squalane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophnone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Trisodium Ethylenediamine Disuccinate, Polyisobutene, Citric Acid, Sodium Hydroxide
May Contain: Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499)
Otc - Questions
www.naturium.com
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