SUN VOYAGE KIT- avobenzone, homosalate, octocrylene, octisalate kit

Sun Voyage Kit by

Drug Labeling and Warnings

Sun Voyage Kit by is a Otc medication manufactured, distributed, or labeled by Koco Life LLC, PhytogenX, Inc., Biogenesis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

84130-004-10 SUN SHIELD ON-THE-GLOW SHEER STICK SPF40

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Purpose

Avobenzone 3% .........................Sunscreen

Homosalate 10%.........................Sunscreen

Octocrylene 10% ........................Sunscreen

Octisalate 5%..............................Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sunprotection measures (see Directions),decreases the risk of skin cancer and earlyskin aging caused by the sun

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

Stop use and ask a doctor if rash occurs

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

Directions

Glide onto body, neck and face 15 minutes before sun exposure for invisible protection.

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 time in the sun, especially from10 a.m.- 2 p.m.

Wear long-sleeved shirts, pants, hats,and sunglasses.

Children under 6 months: Ask a doctor

Inactive Ingredients

C12-15 Alkyl Benzoate, Octyldodecanol, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Isostearyl Linoleate, Dibutyl Lauroyl Glutamide, Polyester-8, Dibutyl Ethylhexanol Glutamide, Silica Silyate, Cocos Nucifera (Coconut) Oil, Tocopherol, Glycine Soja (Soybean) Oil, Bisabolol, Zingiber Officinale (Ginger) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Fragrance (Parfum), Benzyl Salicylate, Hexyl Cinnamal, Linalool, Synthetic Fluorphlogopite, Silica, Iron Oxides (CI 77489), (CI 77491).

Other Information

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

Questions or comments?

Call (858) 252-0099

84130-001-10 SUN SHIELD BODY GLOW SPF50

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Purpose

Avobenzone 3% .........................Sunscreen

Homosalate 10%.........................Sunscreen

Octocrylene 10% ........................Sunscreen

Octisalate 5%..............................Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sunprotection measures (see Directions),decreases the risk of skin cancer and earlyskin aging caused by the sun

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

Stop use and ask a doctor if rash occurs

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

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 time in the sun, especially from10 a.m.- 2 p.m.

Wear long-sleeved shirts, pants, hats,and sunglasses.

Children under 6 months: Ask a doctor

Inactive Ingredients

Octyldodecanol, C12-15 Alkyl Benzoate, Polyamide-3, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Fragrance (Parfum), Persea Gratissima (Avocado) Oil, Hibiscus Sabdariffa Seed Oil, Cocos Nucifera (Coconut) Oil, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aleurites Moluccana Seed Oil, Tocopheryl Acetate, Macadamia Ternifolia Seed Oil, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Mica (CI 77019), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Other Information

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

Questions or comments?

Call (858) 252-0099

84130-011-13 SUNGLAZE SHEER SETTING MIST SUNSCREEN SPF50

Active Ingredients

Avobenzone 3%

Homosalate 0.5%

Octisalate 5%

Octyocrylene 10%

Purpose

Avobenzone 3% .........................Sunscreen

Homosalate 0.5%........................Sunscreen

Octisalate 5% .............................Sunscreen

Octyocrylene 10%.......................Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sunprotection measures (see Directions),decreases the risk of skin cancer and earlyskin aging caused by the sun

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

Stop use and ask a doctor if rash occurs

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

Directions

Shake well before use. With eyes closed, spray generously and evenly over your face while holding spray 8-10 inches away. Apply 15 minutes before sun exposure. Do not spray directly into eyes.

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 time in the sun, especially from10 a.m.- 2 p.m.

Wear long-sleeved shirts, pants, hats,and sunglasses.

Children under 6 months: Ask a doctor

Inactive Ingredients

Alcohol Denat., Butyloctyl Salicylate, Diisopropyl Adipate, Lauryl Lactate, Dicaprylyl Carbonate, Sodium Hyaluronate, Sodium Hyaluronate Crosspolymer, Tetrahexyldecyl Ascorbate, Tocopherol, Citrus Aurantifolia (Lime) Oil, Litsea Cubeba Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Mentha Viridis (Spearmint) Leaf Oil, Citrus Aurantium Peel Oil, Hydrogenated Castor Oil, Oryza Sativa (Rice) Bran Extract, Communis (Castor) Seed Oil, Glycerin, Triethyl Citrate, Gamma Decalactone, Maltol, Dimethyl Heptenal, Hexyl Acetate, Ethyl Butyrate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, t-Butyl Alcohol, Mica, Water/Aqua/Eau, Propanediol, Polyglutamic Acid, Citric Acid, Sodium Benzoate, Limonene, Geraniol, Geranyl Acetate, Terpineol, 3,6-Nonadienol, Tin Oxide, CI 77891 (Titanium DIoxide), CI 77491 (Iron Oxides)

Other Information

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

Questions or comments?

Call (858) 252-0099

PRINCIPAL DISPLAY PANEL

Kopari

Sun Voyage

SPF Kit

INGREDIENTS AND APPEARANCE

SUN VOYAGE KIT 
avobenzone, homosalate, octocrylene, octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-013

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-013-97	1 in 1 KIT; Type 0: Not a Combination Product	11/01/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CONTAINER	30 g
Part 2	1 BOTTLE, PUMP	40 mL
Part 3	1 BOTTLE, PUMP	30 mL

Part 1 of 3

SUN SHIELD ON-THE-GLOW SHEER STICK SPF40 
avobenzone, homosalate, octocrylene, octisalate stick

Product Information
Item Code (Source)	NDC: 84130-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
FARNESOL (UNII: EB41QIU6JL)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LEVOMENOL (UNII: 24WE03BX2T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOSTEARYL LINOLEATE (UNII: 4778M3HR0N)
LINALOOL, (+)- (UNII: F4VNO44C09)
OCTYLDODECANOL (UNII: 461N1O614Y)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
COCONUT OIL (UNII: Q9L0O73W7L)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GINGER (UNII: C5529G5JPQ)
CITRAL (UNII: T7EU0O9VPP)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-004-10	30 g in 1 CONTAINER; 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	11/01/2024

Part 2 of 3

SUNGLAZE SHEER SETTING MIST SUNSCREEN SPF50 
avobenzone, homosalate, octisalate, octyocrylene spray

Product Information
Item Code (Source)	NDC: 84130-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)
HEXYL ACETATE (UNII: 7U7KU3MWT0)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
RICE BRAN (UNII: R60QEP13IC)
LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALCOHOL (UNII: 3K9958V90M)
GERANYL ACETATE (UNII: 3W81YG7P9R)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
STANNOUS OXIDE (UNII: JB2MV9I3LS)
SPEARMINT OIL (UNII: C3M81465G5)
BITTER ORANGE OIL (UNII: 9TLV70SV6I)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYL BUTYRATE (UNII: UFD2LZ005D)
LITSEA OIL (UNII: 2XIW34BN6O)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
LAURYL LACTATE (UNII: G5SU0BFK7O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
GERANIOL (UNII: L837108USY)
CASTOR OIL (UNII: D5340Y2I9G)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
TERPINEOL (UNII: R53Q4ZWC99)
POLYGLUTAMIC ACID (1200 MW) (UNII: MGE3733FR2)
MALTOL (UNII: 3A9RD92BS4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-011-13	40 mL in 1 BOTTLE, PUMP; 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	11/01/2024

Part 3 of 3

SUN SHIELD BODY GLOW SPF50 
homosalate, octocrylene, octisalate, avobenzone gel

Product Information
Item Code (Source)	NDC: 84130-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
AVOCADO OIL (UNII: 6VNO72PFC1)
KUKUI NUT OIL (UNII: TP11QR7B8R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MACADAMIA OIL (UNII: 515610SU8C)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
HIBISCUS SABDARIFFA SEED OIL (UNII: G2X0304IX1)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
COCONUT OIL (UNII: Q9L0O73W7L)
MICA (UNII: V8A1AW0880)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-001-10	30 mL in 1 BOTTLE, PUMP; 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	11/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/01/2024

Labeler - Koco Life LLC (046650159)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	manufacture(84130-011, 84130-013)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Inc.		069117328	manufacture(84130-001, 84130-004, 84130-013)