Active Ingredients
Zinc Oxide 14.2%
Activated Mineral Sunscreen Tinted Cream
FDA Label NDC 83083-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reve Skincare Llc for the product Activated Mineral Sunscreen Tinted (NDC 83083-002). 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, uses, warnings, directions, inactive ingredients, other information, questions or comments?, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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 ask a docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
Directions
• apply generously 15 minutes before sun exposure
• reapply: •at least every 2 hours.
• use a water resistant sunscreen if swimming or sweating
• 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
• children under 6 months of age: Ask a doctor
Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Niacinamide, Butyloctyl Salicylate, Propanediol, Squalene, Aloe Barbadensis Leaf Juice, Sodium Acrylate/Sodium Acyloyldimethyl Tauarate Copolymer, 1,2-Hexanediol, Cetyl Alcohol, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyacetophenone, Polyisobutene, Glycerin, Glyceryl Stearate, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Vaccinium Vitis-Idaea Fruit Extract, Xanthan Gum, Caprylyl/Capryl Glucoside, Sorbitan Oleate, Phenoxyethanol, Jojoba Esters, Citric Acid, Gluconolactone, Plankotn Extract, Alumina, Sodium Benzoate, Potassium Sorbate, Silica, Calcium Glucate. May Contain (+/-): Titanium Dioxide (CI77891), Iron Oxides (CI 774941, 77492, 77499)
Other Information
• protect the product in this container from excessive
heat and direct sun
Questions Or Comments?
Call our Sunshine Concierge: 855-744-6366 (855-Shine-On)
Purpose
Sunscreen
Keep Out Of Reach Of Children.
Keep out of reach of children.
Topical
Topical
Principal Display Panel
83083-002 (83083 002)
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