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Drug Facts
Distributed by:
Neora, LLC, Dallas, TX 75244
1.855.463.7486
www.neora.com
Neora Gel
FDA Label NDC 72935-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neora, Llc for the product Neora (NDC 72935-002). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients
Avobenzone 3%
Homosalate 9.5%
Octisalate 5%
Octocrylene 2.6%
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
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
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- apply liberally 15 minutes before sun exposure.
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- 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
- children under 6 months: ask a doctor
Storage And Handling
Other information
Protect this product from excessive heat and direct sun.
Inactive Ingredient
Inactive ingredients
Water, butyloctyl salicylate, dipropylene glycol, caprylyl methicone, methyl trimethicone, betaine, acrylates copolymer, ammonium acryloyldimethyltarate/VP copolymer, hydroxyacetophenone, propanediol, phenoxyethanol, hydrolyzed wheat protein/PVP crosspolymer, dibutyl ethylhexanoyl glutamide, dibutyl lauroyl glutamide, carbomer, citrus aurantium dulcis (orange) peel oil, dipotassium glycyrrhizate, tocopheryl acetate (Vitamin E), aminomethyl propanol, caesalpinia spinosa fruit extract, tropaeolum majus flower/leaf/stem extract, disocium EDTA, carnosine, butylene glycol, citrus limon (lemon) peel oil, citrus aurantium bergamia (bergamot) fruit oil, silica, biosacharride gum-4, kappaphycus alvarezii extract, aloe barbadensis leaf extract, lavandula angustifolia (lavender) oil, ethylhexylglycerin, potassium sorbate, citrus bioflavonoids (vitamin P), hydroxyphenyl propamidobenzoic acid, ocimum basilicum (basil) oil, pelargonium graveolens flower oil, brassica oleracea italica (broccoli) extract, ascorbyl palmitate (Vitamin C).
Package Label.Principal Display Panel
NEORA™
AGE IQ
INVISI-BLOC™
SUNSCREEN GEL
Broad Spectrum SPF 40
1 fl. oz. / 30 mL
* Please review the disclaimer below.
