Active Ingredients
Titanium Dioxide 5.78%
Zinc Oxide 3.74%
Island Remedy All-day Revitalizing Moisturizer With Spf 30 Cream
FDA Label NDC 53675-160
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aruba Aloe Balm Nv for the product Island Remedy All-day Revitalizing Moisturizer With Spf 30 (NDC 53675-160). 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 active ingredients, purpose, uses, warnings, stop use and consult a doctor, keep out of reach of children., directions, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
• Helps prevent sunburn • Higher SPF gives more sunburn protection.
Warnings
For external use only
Avoid contact with eyes, rinse with water to remove.
Stop Use And Consult A Doctor
if rash or irritation develops and lasts.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply a small amount on area of skin treatment, reapply frequently if necessary.
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 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.
Inactive Ingredients:
Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Water (Aqua/Eau), Cetearyl Isononanoate, Glyceryl Stearate, Cetearyl Alcohol, Ceteareth-20, PEG-20 Glyceryl Stearate, Cetyl Palmitate, Ethylhexyl Methoxycrylene, C12-C15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Hydrogen Dimethicone, Butyloctyl Salicylate, Propylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate (Vitamin E Acetate), Bisabolol, Isostearic Acid, Aluminum Hydroxide, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Arnica Montana Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Symphytum Officinale Leaf Extract, Achillea Millefolium Extract, Calendula Offcinalis Flower Extract, Prunus Serotina (Wild Cherry) Bark Extract, Eugenia Caryophyllus (Clove) Flower Extract, Equisetum Hiemale Extract, Cymbopogon Schoenanthus Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Ascorbic Acid (Vitamin C).
Package Labeling:
Inner Package Labeling:
Outer Package Labeling:
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