Sunkissed By Heaven Unscented Sunscreen Spf 50 Ointment
FDA Label NDC 87189-910

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sunkissed By Heaven, Llc for the product Sunkissed By Heaven Unscented Sunscreen Spf 50 (NDC 87189-910). 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 drug facts, active ingredients, purpose, uses:, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Zinc Oxide 25.00%

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn. 
  • higher SPF gives more sunburn protection
  • 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

Do Not Use

  • on damaged or broken skin.

When Using This Product

  • keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions

Apply liberally 15 minutes before sun exposure
Children under 6 months of age: Ask a doctor
Reapply:
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 the 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, & sunglasses

Other Information

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Beeswax, Jojoba Esters, Lecithin, Simmondsia Chinensis (Jojoba) Seed Oil, Tallow

Questions?

+1 (619) 365-5006

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