Op Sport Sunscreen Spf30
FDA Label NDC 70281-207

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Solskyn Personal Care Llc for the product Op Sport Sunscreen Spf30 (NDC 70281-207). 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, purpose, uses:, warnings:, • keep out of reach of children., directions:, inactive ingredients, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Avobenzone 3.0%, Homosalate 12.0%, Octisalate 5.0%, Octocrylene 5.0%

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.

• Keep Out Of Reach Of Children.

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

Directions:

• Apply liberally 15 minutes prior to sun exposure.

• Re-apply:

      • 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: ask a doctor.

Inactive Ingredients

Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Carbomer, Cholecalciferol, Diisopropyl Adipate, Dimethyl Capramide, Disodium EDTA, Hydroxypropyl Methylcellulose, Idopropynyl Butylcarbamate, Macrocystis Pyrifera Extract, Menthol, Phenoxyethanol, Polyester-8, Propylene Glycol, Silica, Sorbitan Oleate, Tocopheryl Acetate, Triethanolamine, Water

Other Information:

• For use on skin only. Avoid contact with fabric.

• Protect this product from excessive heat and direct sun.

Principal Display Panel

OCEAN Potion
SPORT COOLING
30 BROAD SPECTRUM
SPF 30
SUNSCREEN LOTION
3 FL OZ (89mL)

Ocean Potionsport Cooling30 Broad Spectrumspf 30sunscreen Lotion3 Fl Oz (89ml) (Op Spf30 3oz Sport Cooling Sunscreen Lotion 01)

Ocean Potionsport Cooling30 Broad Spectrumspf 30sunscreen Lotion3 Fl Oz (89ml) (Op Spf30 3oz Sport Cooling Sunscreen Lotion 01)

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