Op Spf45 Face Clear Zinc Potion
FDA Label NDC 70281-203

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 Spf45 Face Clear Zinc Potion (NDC 70281-203). 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

Octinoxate 7.5%

Zinc Oxide 7.0%

Oxybenzone 5.0%

Octisalate 5.0%

Octocrylene 2.0%

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 product is 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 Copolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzote, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Methylparaben, Propylene Glycol, Propylparaben, Sorbitan Stearate, Sorbityl Laurate, Stearyl Alcohol, Triethoxycaprylylsilane, Water, Xanthan Gum

Other Information

  • Protect this product from excessive heat and direct sun.

Questions Or Comments?

Call toll free 1-800-715-3485

Principal Display Panel

Clear Zinc Oxide
Face Potion
sunscreen
Net WT. 1.0 OZ (28.5 g)

Principal Display Panelclear Zinc Oxideface Potionsunscreennet Wt. 1.0 Oz (28.5 G) (Op Face 45 Zinc 01)

Principal Display Panelclear Zinc Oxideface Potionsunscreennet Wt. 1.0 Oz (28.5 G) (Op Face 45 Zinc 01)

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