Poolside Orange Creme Spf 30 Scented Sunscreen Liquid
FDA Label NDC 85179-028

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by I World Llc for the product Poolside Orange Creme Spf 30 Scented Sunscreen (NDC 85179-028). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Homosalate 10%, Octocrylene 8%, Octisalate 5%, Octinoxate 5%, Avobenzone 3%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

Skin cancer/skin aging alert

  • Spending time in the sun increases your risk of skin cancer and early skin aging.
  • This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 Doctor If

  • rash occurs.

Keep Out Of Reach Of Children.

  • If product is swallowed get medical help or contact a poison control center right away.

Directions

  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 month: ask a doctor.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

ISODODECANE, RICINUS COMMUNIS (CASTOR) SEED OIL, CETEARYL ALCOHOL, CETYL ESTERS, HYDROGENATED CASTOR OIL, BUTYLOCTYL SALICYLATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, GLYCERYL STEARATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERYL CAPRYLATE, FRAGRANCE, CALOPHYLLUM INOPHYLLUM SEED OIL, POLYHYDROXYSTEARIC ACID, TOCOPHEROL, ALUMINUM HYDROXIDE, WATER, BUTYLENE GLYCOL, BHT, SODIUM SULFATE, SODIUM CHLORIDE, CROCUS SATIVUS FLOWER EXTRACT, FD&C YELLOW NO.6 ALUMINUM LAKE (CI 15985).

Package Labeling:

Label6 (Label6)

Label6 (Label6)

* Please review the disclaimer below.