NEORA INVISIBLOC SUNSCREEN GEL BROAD SPECTRUM SPF40- avobenzone, homosalate, octisalate lotion

NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40 by

Drug Labeling and Warnings

NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION, COSMAX USA. CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone 3%

Homosalate 9.5%

Octisalate 5%

PURPOSE

Purpose

Sunscreen

USES

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 cause by the sun

Warnings

Warnings

For extenal use only

Do not useon damaged or broken skin

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

Stop use and ask a doctor ifrash occurs

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Directions

• apply liberrally 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 of age:ask a doctor

OTHER INFORMATION

Other information

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

INACTIVE INGREDIENT

Inactive ingredients:

Water, butyloctyl salicylate, dipropylene glycol, acrylates copolymer, caprylyl methicone, methyl trimethicone, betaine, ammonium acryloyldimethyltaurate/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, disodium EDTA, carnosine, butylene glycol, pentylene glycol, silica, citrus limon (lemon) peel oil, citrus aurantium bergamia (bergamot) fruit oil, biosaccharide 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), limonene, linalool, citral.

PRINCIPAL DISPLAY PANEL

Primary Packaging

PRINCIPAL DISPLAY PANEL

Secondary Package

INGREDIENTS AND APPEARANCE

NEORA INVISIBLOC SUNSCREEN GEL BROAD SPECTRUM SPF40 
avobenzone, homosalate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-157
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CITRUS LIMON FLOWERING TOP OIL (UNII: 4C38SS0J60)
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)
CITRAL (UNII: T7EU0O9VPP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
CARNOSINE (UNII: 8HO6PVN24W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROPAEOLUM MAJUS FLOWER (UNII: 7FV667B00B)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
BROCCOLI SPROUT (UNII: 128UH9LOAE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BASIL OIL (UNII: Z129UMU8LE)
BETAINE (UNII: 3SCV180C9W)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PROPANEDIOL (UNII: 5965N8W85T)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ORANGE OIL (UNII: AKN3KSD11B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BRASSICA OLERACEA VAR. BOTRYTIS WHOLE (UNII: 87M72T7VW1)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-157-01	1 in 1 CARTON	06/01/2023
1		30 mg 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 Drug	M020	06/01/2023

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA. CORPORATION		010990210	manufacture(68577-157)