Otc - Active Ingredient
Active Ingredient Purpose
Zinc Oxide........ ....Sunscreen
Illuminating Spf 50 Plus Drops Broad Spectrum Sunscreen Lotion
FDA Label NDC 56152-0253
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Enterprise Ltd for the product Illuminating Spf 50 Plus Drops Broad Spectrum Sunscreen (NDC 56152-0253). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
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.
Indications & Usage
Stop use and ask a doctor is rash occurs
Warnings
Warnings
For external use only
When using this product keep out of eyes, rinse with water to remove.
Dosage & Administration
Directions
- Shake well before use
- Apply liberally 15 minutes before sun exposure
- Reapply
- After 80 minutes of swimming or sweating
- immediately after towel drying
- Sun Protection Meaures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regurlarly use a sunscreen with an SPF of 15 or higher, and other sun protection meaures, including:
- limit time under the sun, especially from 10:00 a.m. to 2:00 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months of age: ask doctor
Inactive Ingredient
Inactive Ingredients
C13-15 Alkane, Aqua/water/Eau, Ethyl Macadamiate, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polyricinoleate, Ectoin, Hydroxyectoin, Isostearic acid, Lecithin, Trisodium Ethylenediamine Disuccinate, Quaternium-90 Bentonite, Fragrance/Parfum, Citrus Aurantium Dulcis (Orange) Peel Oil, Triethyl Citrate, Tocopherol, Malic Acid, Stearyl Triethoxysilane, Sodium Chloride, Ethylhexylglycerin, Phenoxyethanol, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499)
Other Safety Information
Other Information
Protect the product from excessive heat and direct sun
Package Label.Principal Display Panel
Kate Somerville
Mineral SPF 50+
Hydrakate
Illuminating SPF 50+ Drops
Broad Spectrum Sunscreen
Water Resistant (80 Minutes)
50 mL 1.7 Fl. Oz
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