Otc Active Ingredients
Active ingredients Purpose
Homosalate 5.0% Sunscreen
Octocrylene 5.0% Sunscreen
Octisalate 5.0% Sunscreen
Avobenzone 3.0% Sunscreen
Pacifica Sun Dreams Illuminating Spf Foam Aerosol, Foam
FDA Label NDC 61197-700
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 Sun Dreams Illuminating Spf Foam (NDC 61197-700). 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 otc active ingredients, otc purpose, indications & usage, warnings, keep out of reach of children, dosage & administration, inactive ingredients, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc Purpose
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.
Indications & Usage
Helps prevent sunburn.
Warnings
Warnings
For external use only.
- Do not use on damaged or broken skin.
- Stop use & ask a doctor if rash occurs.
- When using this product, keep out of eyes.
- Rinse with water to remove.
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center right away.
Keep Out Of Reach Of Children
- Keep out of reach ofchildren.
Dosage & Administration
Directions
- Shake well before use.
- Apply liberally 15 minutes before sun exposure.
- Use water-resistant sunscreen if swimming or sweating.
- Reapply after swimming or sweating.
- Reapply at least every 2 hours.
- Sun protection measures.
- Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m.-wear long sleeve shirts, pants, hats & sunglasses.
Inactive Ingredients
Inactive ingredients:
agua (eau), butyloctyl salicylate, lauryl glucoside, polyglyceryl-2 dipolyhydroxystearate, sodium lauryl sarcosinate, coconut alkanes, coco-caprylate/caprate, ethylhexyl methoxycrylene, sodium stearoyl glutamate, phenoxywethanol, disodium cocoyl glutamate, cocamidopropyl betaine, eclipta prostrata extract, melia azadirachta leaf extract, moringa pterygosperma oil, xanthan gum, sodium phytate, ethylhexylglycerin, curcuma longa (turmeric) root extract, niacinamide, magnesium sulfate, parfum.
Storage And Handling
Other information. Protect this product from excessive heat & direct sun. Can stain clothing, keep away from clothes.
Questions Or Comments?
Questions or comments?
https://support.pacificabeauty.com/en-US/contact
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