Otc - Active Ingredient
Zinc Oxide 14.0%
Counter Beauty Dew Skin Tinted Moisturizer No. 5 Lotion
FDA Label NDC 84435-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by G2g Ventures, Pbc for the product Counter Beauty Dew Skin Tinted Moisturizer No. 5 (NDC 84435-105). 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, indications & usage, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & 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.
Warnings
For external use only.
Otc - Do Not Use
On damaged or broken skin.
Otc - Stop Use
rash occurs.
Otc - When Using
Keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contaact a Poison Control Center right away.
Dosage & Administration
- Apply as needed daily
- Apply liberally and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months: Ask a doctor.
- Sun Protection Measures Spending time in the sun increases the 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.
Other Safety Information
- Protect the product in this container from excessive heat or direct sun.
Inactive Ingredient
Water, Caprylic/Capric Triglyceride, Coco-Caprylate, Trimethylsiloxysilicate, Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Octyldodecyl Oleate, Ethylhexyl Palmitate, Isopropyl Myristate, Dimethicone, Magnesium Sulfate, Beeswax, Gluconolactone, Glycerin, Isoeicosane, Propanediol, Hydrogenated Castor Oil, Sodium Chloride, Ribes Nigrum (Black Currant) Seed Oil, Octyldodecanol, Tetrahexyldecyl Ascorbate, Sodium Benzoate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Octyldodecyl Stearoyl Stearate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Paeonia Suffruticosa Root Extract, Calcium Gluconate, Rosa Damascena Flower Oil, Citrus Aurantium Dulcis (Orange) Oil, Salvia Sclarea (Clary) Oil, Vanilla Planifolia Fruit, Rosmarinus Officinalis (Rosemary) Leaf Extract, Solidago Virgaurea (Goldenrod) Extract ,Tocopherol ,Sodium Hyaluronate , May Contain (+/-): Titanium Dioxide (CI 77891) Yellow Iron Oxide (CI 77492) Iron Oxides (CI 77491) Iron Oxide (CI 77499), Mica (CI 77019)
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