Pacifica Cc Broad Spectrum Spf 17 Medium
FDA Label NDC 61197-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pacifica Beauty, Llc for the product Pacifica Cc Broad Spectrum Spf 17 Medium (NDC 61197-001). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts


Active Ingredient

ZInc Oxide 11.4%

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

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 OCCURS

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
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply 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 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:

water (aqua), caprylic/capric triglyceride, sorbitan sesquioleate, dimethicone, potassium cetyl phosphate, glycerin, silica, jojoba esters, ceteraryl olivate, sorbitan olivate, mica, citric acid, potassium sorbate, sodium dehydroacetate, sodium benzoate, fragrance, sodium hyaluronate, cocos nucifera (coconut) water, withania somnifera root extract, carthamus tinctorius (safflower) seed oil, macrocystis pyrifera extract, linalool, amyl cinnamal, titanium Dioxide, CI 77891, Iron oxides CI 77491, CI 77492, and CI77499

Other Information

Protect this product from excessive heat and direct sun

Questions Or Comments?

Call toll free 1-888-322-2466 (8am to 5pm Pacific time, Monday-Friday)

Package Labeling:

Image Description (Label2)

Image Description (Label2)

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