Active Ingredients
Zinc Oxide 23.8%
Pure Protect Mineral Sunscreen Stick Spf50 Stick
FDA Label NDC 84130-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Koco Life Llc for the product Pure Protect Mineral Sunscreen Stick Spf50 (NDC 84130-010). 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, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Zinc Oxide 23.8%................Sunscreen
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.
Warnings
For external use only.
Otc - Do Not Use
Do not use
- on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply (liberally or generously) to face, neck, and body 15 minutes before sun exposure.
- Reapply: At least every 2 hour. Use a water resistant sunscreen if swimming or sweating.
- Sun Protection Measures
- Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher & 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
Helianthus Annuus (Sunflower) Seed Cera/Wax/Cire, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Coco-Caprylate, C12-15 Alkyl Benzoate, Ethyl Macadamiate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecanol, Argania Spinosa Kernel Oil, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Copernicia Cerifera Cera (Copernicia Cerifera (Carnauba) Wax, Cire de Carnauba), Methyl Dihydroabietate, Helianthus Annuus (Sunflower) Seed Oil, Candelilla Cera (Euphorbia Cerifera (Candelilla) Wax, Cire de Candelilla), Tocopherol, Jojoba Esters, Behenyl Behenate, Polyhydroxystearic Acid, C18-38 Alkyl Hydroxystearoyl Stearate, Sorbitan Sesquioleate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Bisabolol, Malic Acid, Citric Acid, Canola Oil (Huile de Colza) CI 77491/77492 (Iron Oxides), Farnesol
Other Information
Protect the product in this container from excessive heat and direct sun.
Questions/Comments
Call (858) 252-0099
Package Label.Principal Display Panel
Kopari
Pure Protect
Mineral
Sunscreen
Stick SPF 50+
Pure Protect Ecran
Solaire Mineral
En Stick FPS 50+
Net Wt. 0.7 oz. | Poids Net 20 G
* Please review the disclaimer below.
