Otc - Active Ingredient
Purpose Sunscreen
Avobenzone 3.0%, Homosalate 15%, Octocrylene 8.0%, Octisalate 5.0%, Oxybenzone 5.0%
4-in-1 Broad Spectrum Spf 50 Sunscreen
FDA Label NDC 80030-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bio Jouvance for the product 4-in-1 Broad Spectrum Spf 50 Sunscreen (NDC 80030-001). 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 otc - active ingredient, uses, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
helps prevent sunburn
if used as directed with other sun protection measures (see directions), decrease 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 Poison Control Center right away.
Indications & Usage
Stop use and ask a Physician if rash occurs.
Warnings
For external use only. Do not used on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove.
Dosage & Administration
- apply liberally 15 minutes before sun exposure
- re-apply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every two hours
- Sun Protection Meaures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regurlarly use a sunscreen with an SPF of 15 or higher, and other sun protection meaures, including:
- limit time under the sun, especially from 10:00 a.m. to 2:00 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a Physician if exposure would be advised.
Inactive Ingredient
water, stearic acid, glyceryl stearate, PEG-100 stearate, elaeis guineensis kernel oil, aloe barbadensis leaft ectract, retinyl palmitate, pyridoxine hydrochloride cyanocobalamin, ascorbic acid, tocopheryl acetate, sodium hyaluronate crosspolymer, dimethicone, polysorbate 60, carbomer, triethanolamine, DMDM hydantoin, diazolidinyl urea, iodopropynyl butylcarbamate
Other Safety Information
protect this product from excessive heat and direct sun
Questions or comments?
Call toll free 1-800-272-1716
Package Label.Principal Display Panel
BIO JOUVANCE
PARIS
4-in-1 BROAD SPECTRUM SPF 50 SUNSCREEN
FACE/BODY
2 FL. OZ. 60 ml
DISTRIBUTED BY BIOJOUVANCE INC.
LOS ANGELES, CA 90039
WWW.BIOJOUVANCE.COM
* Please review the disclaimer below.
