NEORA AGE IQ INVISI-BLOC SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene gel

Neora by

Drug Labeling and Warnings

Neora by is a Otc medication manufactured, distributed, or labeled by Neora, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3%

Homosalate 9.5%

Octisalate 5%

Octocrylene 2.6%

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.

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

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).

SPL UNCLASSIFIED SECTION

Distributed by:

Neora, LLC, Dallas, TX 75244

1.855.463.7486

www.neora.com

PRINCIPAL DISPLAY PANEL

NEORA™

AGE IQ

INVISI-BLOC™

SUNSCREEN GEL

Broad Spectrum SPF 40

1 fl. oz. / 30 mL

INGREDIENTS AND APPEARANCE

NEORA  AGE IQ INVISI-BLOC SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72935-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BETAINE (UNII: 3SCV180C9W)
PROPANEDIOL (UNII: 5965N8W85T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ORANGE OIL (UNII: AKN3KSD11B)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARNOSINE (UNII: 8HO6PVN24W)
LEMON OIL (UNII: I9GRO824LL)
BERGAMOT OIL (UNII: 39W1PKE3JI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
WATER (UNII: 059QF0KO0R)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
BASIL OIL (UNII: Z129UMU8LE)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
BROCCOLI (UNII: UOI4FT57BZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72935-002-30	1 in 1 CARTON	05/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2019

Labeler - Neora, LLC (055050917)