Otc - Active Ingredient
Active ingredients:
Zinc Oxide 7.5%
Titanium Dioxide 4.4%
Tinted Moisturizer Spf 20
FDA Label NDC 63550-158
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kamins Dermatologics Inc. for the product Tinted Moisturizer Spf 20 (NDC 63550-158). 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
Purpose: Sunscreen
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & Usage
This cream is enriched with moisturizing acai oil to help skin remain hydrated while adding a touch of color and glow to your skin.
Uses
■ Helps prevent sunburn.
■ Higher SPF gives more sunburn protection.
■ Provides moderate protection against sunburn.
Warnings
Warnings
■ For external use only.
■ When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.
■ Stop use and ask a doctor if rash or irritation develops and lasts.
■ If swallowed, seek medical assistance or contact a Poison Control
Center immediately.
Dosage & Administration
Directions
■ Apply in the morning and prior to sun exposure. Reapply as needed.
■ Children under 6 months of ask: ask a doctor.
Inactive Ingredient
Inactive ingredients: Aqua/Water/Eau, Caprylic/Capric Triglyceride, Oleyl Oleate, Polyglyceryl-2 Dipolyhydroxystearate, Pentaerythrityl Tetraisostearate, Butylene Glycol, Cyclopentasiloxane, PEG/PPG-20/15 Dimethicone, Triethoxycaprylylsilane, Sodium Lauryl Glucose Carboxylate, Lauryl Glucoside, Glycerin, Xanthan gum, Magnesium Aluminum Silicate, Acai Fruit Oil, Citric Acid, Isononyl Isononanoate, Isopropyl Titanium Triisostearate, Synthetic Wax, Caprylyl Glycol, Phenoxyethanol, Sorbic Acid, Iron oxides (CI 77491, 77492).
Package Label.Principal Display Panel
B. KAMINS
TINTED MOISTURIZER SPF15
50mL / 1.7 fl.oz
NPN 80026968
image/jpg
Tinted Moisturizer Front Panel Image (Tinted Moisturizer)
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