Occulus
FDA Label NDC 13630-0089

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prime Packaging, Inc. for the product Occulus (NDC 13630-0089). 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 principal display panel - 125g can label, active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Principal Display Panel - 125G Can Label

Principal Display Panel (125g Can Label)

Principal Display Panel (125g Can Label)

SKIN HYDRATING

TOPICAL FOAM

SOLOXIDE 30

Broad Spectrum SPF 30

SUNSCREEN FOAM

Water resistant

(80 minutes)

NET WT.4.4 OZ (125g)

Active Ingredients

Avobenzone 2 %, Homosalate 7.5%, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

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

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Directions

  • Hold can upright. Shake well before each application.
  • Apply liberally and spread evenly by hand 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 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

Butane, Butylparaben, Butylphthalimide, Dimethicone,Disodium EDTA, Ethylparaben, Glycerin, Isobutylparaben, Isopropylphthalimide, Methylparaben, Phenoxyethanol, Polysorbate-20, Propane, Propylene Glycol, Propylparaben, PVP, Stearic Acid, Styrene/Acrylates Copolymer, Triethanolamine, VP/Hexadecene Copolymer, Water

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