People4ocean Spf50 Sunscreen
FDA Label NDC 73192-030

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by P4o Distribution Pty Ltd for the product People4ocean Spf50 Sunscreen (NDC 73192-030). 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, when using this product, stop use and ask a doctor if, 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

Active Ingredient

Zinc oxide 22.5%

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

When Using This Product

  • keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

  • rash occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally and evenly 15 minutes before sun exposure
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.
  • Sun Protection Measures: 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:
  • 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

Other Information

  • store below 86°F (30°C)
  • protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Purified water, Coco-Caprylate/Caprate, Caprilic/capric triglyceride°, Polyglyceryl-3 Polyricinoleate, Dimethicone, Octyl Palmitate, Isostearic Acid°, Butylene glycol, PEG-30 dipolyhydroxystearate, Beeswax°, Glycerol, Polyethylene, Phenoxyethanol, Glyceryl oleate, Ethylhexylglycerin, Lavender Oil*, Ylang Ylang Flower Oil*, Patchouli Leaf Oil*, Vetiver Root Oil*, Geranium Oil*, Xanthan gum. °Organic | *Natural.

Package Labeling:

Label2 (Label2)

Label2 (Label2)

* Please review the disclaimer below.