Active Ingredients
Titanium Dioxide 3.1%
Zinc Oxide 10.49%
Prime Time Daily Protecting Primer Spf 30 Lotion
FDA Label NDC 51514-0364
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Autumn Harp Inc. for the product Prime Time Daily Protecting Primer Spf 30 (NDC 51514-0364). 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, indications & usage, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Sunscreen
Sunscreen
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 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
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- Sun Protection Measures:
- limit time in the sun, especially from 10 am - 2 pm
- wear long sleeve shirts, pants, hats and sunglasses
- children under 6 months of age: Ask a doctor
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:
Other Information
Protect this product in this container from excessive heat and direct sun.
Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Undecane, Polyglyceryl-6 Polyricinoleate, Tapioca Starch, Glycerin, Tridecane, Magnesium Sulfate, Polyglyceryl-2 Isostearate, Tocopherol, Hydrogenated Vegetable Oil, Phenoxyethanol, Glyceryl Isostearate, Disteardimonium Hectorite, Polyhydroxystearic Acid, Propanediol, Bisabolol, Stearic Acid, Iron Oxide (CI 77492), Alumina, 1,2-Hexanediol, Isononyl Isononanoate, Camellia Japonica Seed Oil, Theobroma Cacao (Cocoa) Extract, Butylene Glycol, Isopropyl Myristate, Isostearic Acid, Iron Oxides (CI 77491), Caprylhydroxamic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Biosaccharide gum-4, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Propylene Carbonate.
Questions?
Call toll free 1-888-795-4747
Principle Display Panel
Image Content
Tube (Tube Eu 12731538 25 61464 Dailyprotecting O10 Bc)
Carton (Carton Us 12731537 Ctn Bc Revised)
* Please review the disclaimer below.
