Otc - Purpose
Micronized Zinc Oxide 10%..............Sunscreen
Micronized Titanium Dioxide 6%..............Sunscreen
Sunscreen
Chorus Supernatural Shield Spf30 Broad Spectrum Sunscreen
FDA Label NDC 69711-361
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Soleil for the product Chorus Supernatural Shield Spf30 Broad Spectrum Sunscreen (NDC 69711-361). 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 chorus supernatural shield spf 30+ broad spectrum sunscreen face cream, otc - purpose, otc - active ingredient, indications & usage, warnings, dosage & administration, inactive ingredient, chorus supernatural protect spf30+ broad spectrum sunscreen lotion, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Micronized Zinc 10%
Micronized Titanium Dioxide 6%
Micronized Zinc Oxide 11%
Micronized Titanium Dioxide 8%
Indications & Usage
The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years reduces the chance of these harmful effects.
Helps prevent sunburn
If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by sun
The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years reduces the chance of these harmful effects.
Helps prevent sunburn
If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by 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 consult a doctor if rash occurs.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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 consult a doctor if rash occurs.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Apply liberally 15 minutes before sun exposure
Reapply
After 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
Children under 6 months of age: ask a doctor
Apply liberally 15 minutes before sun exposure
Reapply
After 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
Children under 6 months of age: ask a doctor
Inactive Ingredient
Aqua, Aloe barbadensis Leaf Juice, Grape Seed Oil, Glycerine, Jojoba Oil,
Caprylic/Capric Triglyceride, Cetearyl Olivate, Sorbitan Olivate, Salicylic Acid, Sorbic Acid,
Cetearyl Alcohol, Citric Acid, Calendula officinalis Seed Oil, Glyceryl Isostearate,
Polyhydroxystearic Acid, Evening Primrose Oil, Mica, Mauritia flexuosa Fruit Oil, Aluminum Hydroxide,
Lauric Acid, Tapioca, Iron Oxide Yellow, Potassium Sorbate, Aminoprypyl Ascorbyl Phosphate,
Disodium Lauriminodipropionate Tocopheryl Phosphates, Xanthan Gum, Sodium Benzoate
Water, Coco-Caprylate, Dicaprylyl Carbonate, Lauryl Glucoside,
Polyglyceryl-2 Dipolyhydroxystearate, Glycerin, Microcrystalline Cellulose,
Cellulose Gum, Green Tea Extract, DL-Panthenol, Sodium Ascorbyl Phosphate,
D-alpha Tocopheryl Acetate, Phytic Acid, Triethoxycaprylylsilane, Polyhydroxystearic Acid,
Xanthan Gum, Benzyl Alcohol, Ethylhexylglycerin, D-alpha Tocopherol
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