Otc - Active Ingredient
Active Ingredients Purpose
Homosalate 10.00% Sunscreen
Octocrylene 8.00% Sunscreen
Avobenzone 3.00% Sunscreen
Defense Total High Protection Spf 50 No Color Daily Non-greasy Face Protection Lotion
FDA Label NDC 14141-140
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bel Star S.a. (colombia) for the product Defense Total High Protection Spf 50 No Color Daily Non-greasy Face Protection (NDC 14141-140). 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 ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, 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 and early skin aging caused by the sun.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a poison Control Center right away
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
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.
Dosage & Administration
Directions
- Apply generously and evenly 15 minutes before sun exposure
- Reapply:
- After 40 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 this risk, regularly use a
sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun
protection measures including: • limit your time in the sun, especially from 10
a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: ask a doctor.
Inactive Ingredient
lnactive lngredients
Water, styrene/acrylates copolymer, potassium cetyl phosphate, c12·15 alkyl benzoate, cyclohexasiloxane, dimethicone,
phenethyl benzoate,polymethylsilsesquioxane, propylene glycol, vp/eicosene copolymer, trimethylsiloxysilicate, phenoxyethanol,
cetyl palmitate, xanthan gum, physalis angulata extract, caprylic/capric triglyceride, cetearyl alcohol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylates/c10·30 alkyl acrylate crosspolymer, caprylyl glycol, disodium edta, tocopheryl acetate, citric acid, butylene glycol, oxothiazolidine.
Package Label.Principal Display Panel
High Protection SPF 50
No color
Water resistant (40 minutes)
with collagen protectors
daily non-greasy
Face protection Lotion
1 fl. oz. (30 ml)
* Please review the disclaimer below.
