Otc - Active Ingredient
Active ingredients
Zinc Oxide 22.95%
The Mineral Lip One Spf 45 Nourishing Lip Tint Vanilla Cloud Lipstick
FDA Label NDC 68577-223
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa, Corp for the product The Mineral Lip One Spf 45 Nourishing Lip Tint Vanilla Cloud (NDC 68577-223). 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, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Uses
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - Stop Use
Stop use and ask a doctor if rash occurs
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.
Directions
Directions
- Apply generously to lips before sun exposure.
- Reapply frequently
- Do not swallow
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. 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 Ingredient
Inactive Ingredients
Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Jojoba Esters, Pentaerythrityl Tetraisostearate, Butyloctyl Salicylate, Diisostearyl Malate, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Polyglyceryl-4 Isostearate, Moringa Oil/Hydrogenated Moringa Oil Esters, Polyhydroxystearic Acid, Silica, Euphorbia Cerifera (Candelilla) Wax, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Sorbitan Isostearate, Stearalkonium Hectorite, Flavor, Iron Oxides (Ci 77491), Propylene Carbonate, Iron Oxides (Ci 77492), Polyglycerin-3, Acacia Decurrens Flower Wax, Iron Oxides (Ci 77499), Dehydroacetic Acid, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, Tocopherol
Questions Or Coments
Questions or comments?
1-888-426-0695. Monday-Friday, 9 a.m. - 5 p.m. EST
Package Label.Principal Display Panel
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD 5.2g/.18oz
Cartridge (Pp Pkg)
Label (Lbl Vanilla)
Carton (Sp Vanilla)
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