Otc - Active Ingredient
Active Ingredients
Zinc Oxide 13.5%
Prime Prometics Lipoil Spf 35 Nude Rose Oil
FDA Label NDC 68577-227
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 Prime Prometics Lipoil Spf 35 Nude Rose (NDC 68577-227). 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 - 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
Otc - Purpose
Purpose
Sunscreen
Uses
Uses
- Helps prevent sunburn
- I 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
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 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 Poison Control Center right away.
Directions
DIRECTIONS
- Apply generously and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use water resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your risk of certain cancer and early aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months:
Ask doctor.
Other Information
OTHER INFORMATION
Protect Product in this container from excessive heat and direct sun
Inactive Ingredient
INACTIVE INGREDIENTS:
Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Microcrystalline Wax, Silica Dimethyl Silylate, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Isononyl Isononanoate, Sorbitan Isostearate, Iron Oxides (CI 77491), Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Flavor, Iron Oxides (CI 77499), Menthone Glycerin Acetal, Dehydroacetic Acid, Rosa Canina Seed Oil, Mangifera Indica (Mango) Seed Butter, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, Tocopherol, Lecithin.
Package Label.Principal Display Panel
Tube (Pp Nuder)
Carton (Sp Nuders)
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