Active Ingredients
Avobenzone 3.0%
Homosalate 15.0%
Octocrylene 2.35%
Octyl Salicylate 5.0%
Oxybenzone 5.0%
Op Protect And Renew Body Spf 45
FDA Label NDC 70281-212
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 Protect And Renew Body Spf 45 (NDC 70281-212). 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.
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.
• Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
• Apply liberally 15 minutes before sun exposure.
• Re-apply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every two 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 Crossolymer, Butylparaben, Caprylyl Methicone, Citric Acid, Diisostearyl Malate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hyrdogenated Coco-Glycerides, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Potassium Cetyl Phosphate, PPG-17/IPDI/DMPA Coploymer, Polydimethylsiloxane, Saccaride Isomerate, Silica, Sodium Citrate, Tocopheryl Acetate, Triethanolamine, Water
Other Information
• Protect this product from excessive heat and direct sun.
• For use on skin only. Avoid contact with fabric.
Principal Display Panel
Ocean Potion
Protect
& Renew
Body
SPF 45
6 fl oz (177 mL)
Principal Display Panelocean Potionprotect& Renewbodyspf 456 Fl Oz (177 mL) (Op Spf45 6oz Protect Renew Body 72 Hr Moisture 01)
* Please review the disclaimer below.
