Otc - Active Ingredient
Active ingredient.....Purpose
Zinc Oxide 15%......Sunscreen
Impeccable Skin Sunscreen Foundation Broad Spectrum Spf 30 Nude Cream
FDA Label NDC 56152-0261
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 Enterprises Ltd for the product Impeccable Skin Sunscreen Foundation Broad Spectrum Spf 30 Nude (NDC 56152-0261). 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, package label.principal display panel, 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 if rash occurs
Warnings
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.
Dosage & Administration
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: Ask a doctor
- Sun 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 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
Inactive Ingredient
Inactive Ingredients Aloe Barbadensis Leaf Juice, Purified Water, Caprylic/Capric Triglyceride, C13-15 Alkane, Glycerin, Lauroyl Lysine, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, C12-15 Alkyl Benzoate, Stearalkonium Hectorite, Leuconostoc/Radish Root Ferment Filtrate, Dipalmitoyl Hydroxyproline, Tetrahexyldecyl Ascorbate, Tocopherol, Sambucus Nigra Fruit Extract, Kappaphycus Alvarezii Extract, Caesalpinia Spinosa Fruit Extract, Melanin, Bisabolol, Hyaluronic Acid, Camellia Sinensis Leaf Extract, Phospholipids, Polyglyceryl-2 Stearate, Lactobacillus, Cocos Nucifera (Coconut) Fruit Extract, Ethylhexylglycerin, Sodium Chloride, Propylene Carbonate, Isopropyl Titanium, Triisostearate, Titanium Dioxide (C.I. 77891) Iron Oxides (C.I. 77492, C.I. 77491, C.I. 77499)
Package Label.Principal Display Panel
Suntegrity
Impeccable Skin
Sunscreen Foundation
Broad Spectrum SPF 30
Non-Nano Zinc Oxide
Medium Coverage CC Cream Satin Finish
NET WT 2 OZ (56.7 g)
Impeccable Skin Sunscreen Foundation (Impeccable Skin 151.152.153)
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