Sunplus Mist Sunscreen Spf 50 Liquid
FDA Label NDC 84661-894

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sunplus Skin Care Llc for the product Sunplus Mist Sunscreen Spf 50 (NDC 84661-894). 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 3.00%
Octisalate 5.00%
Octocrylene 3.00%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn. • higher SPF gives more sunburn protection. • retains SPF after 40 minutes of swimming or sweating • 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 and as needed. • 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 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.

Other Information

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

Inactive Ingredients

Actinidia Chinensis (Kiwi) Fruit Extract, Aloe barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Garcinia Mangostana (Mangosteen) Extract, Helianthus Annuus (Sunflower) Oil, Carthamus Tinctarius (Safflower) Oil, Hydrogenated Methyl Abietate, Linum usitatissimum (Linseed) Oil, Lycium Barbarum (Goji) Fruit Extract, Parfum (Fragrance), Punica Granatum (Pomegranate) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

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