Back9ine Skincare Pure Invisible Sunscreen Spf 50 Gel
FDA Label NDC 85536-585

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Back 9ine Skincare, Llc for the product Back9ine Skincare Pure Invisible Sunscreen Spf 50 (NDC 85536-585). 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, stop use and ask a doctor if, when using this product, 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%
Homosalate 7%
Octisalate 5%
Octocrylene 10%

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.

Stop Use And Ask A Doctor If

if rash or irritation occurs.

When Using This Product

keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°.

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
    • do not spray directly on face. Spray into hands and apply to face
    • use in well ventilated areas
  • 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

Inactive Ingredients

Adansonia Digitata Oil, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Seed Extract, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Hippophae Rhamnoides Fruit Oil, Isododecane, Tocopherol, Tridecyl Salicylate

Other Information

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

Questions?

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