Op Protect And Renew Face Spf 35
FDA Label NDC 70281-211

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 Face Spf 35 (NDC 70281-211). 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

Active Ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octocrylene 2.7%

Octyl Salicylate 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 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

Caprylyl Methicone, Carbomer, Cetearyl Alcohol, Disodium EDTA, Ethylhexlglycerin, Glycerin, Phenoxyethanol, Palmitoyl Tripeptide-5, Potassium Cetyl Phosphate, Tapioca Starch, Tocopherol, Tocopherol Acetate, Triethanolamine, Water, Xanthan Gum

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
Protect
& Renew
face
SPF 35
3 fl oz (89ml)

Principal Display Panelocean Potionprotect& Renewfacespf 353 Fl Oz (89ml) (Op Spf35 3oz Protect Renew Face 01)

Principal Display Panelocean Potionprotect& Renewfacespf 353 Fl Oz (89ml) (Op Spf35 3oz Protect Renew Face 01)

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