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  5. Label Information: Op Protect And Renew Body Spf 45

FDA Label for Op Protect And Renew Body Spf 45

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS:
    5. • KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS:
    7. INACTIVE INGREDIENTS
    8. OTHER INFORMATION
    9. PRINCIPAL DISPLAY PANEL

Op Protect And Renew Body Spf 45 Product Label

The following document was submitted to the FDA by the labeler of this product Solskyn Personal Care Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Avobenzone 3.0%

Homosalate 15.0%

Octocrylene 2.35%

Octyl Salicylate 5.0%

Oxybenzone 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



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

PRINCIPAL DISPLAY PANELOcean PotionProtect& RenewBodySPF 456 fl oz (177 mL) - op spf45 6oz protect renew body 72 hr moisture 01


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