Active Ingredient
Zinc Oxide 25%
Primally Pure Unscented Sunscreen Spf 30 Cream
FDA Label NDC 88005-001
12 label sections · Submitted to the FDA by Primally Pure Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Primally Pure Llc for the product Primally Pure Unscented Sunscreen Spf 30 (NDC 88005-001). 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 ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, when using this product, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
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.
Stop Use And Ask A Doctor If
rash occurs.
When Using This Product
keep out of eyes. Rinse with water to remove.
Directions
For full protection, apply generously and evenly 15 minutes before sun exposure.
Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours.
- Spending time in the sun increasing your risk of skin cancer and early skin aging. To decrease the 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 10am-2pm
- wear long-sleeved shirts, pants, hats, and sunglasses.
- For children under 6 months of age: ask a doctor.
Sun Protection Measures:
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Caprylic/Capric Triglyceride, Tallow from 100% Grass-Fed Cows, Organic Beeswax, Organic Coconut Oil, Organic Mango Butter, Tocopherol
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.
Principal Display Panel
Primally Pure Unscented Sunscreen SPF 30 - Principal Display Panel
Carton: Primally Pure Unscented Spf 30 (Outer Carton)
Tube: Primally Pure Unscented Spf 30 (Inner Tube)
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