SUNS OUT FUNS OUT- avobenzone, homosalate, octisalate, octocrylene kit

Suns Out Funs Out by

Drug Labeling and Warnings

Suns Out Funs Out by is a Otc medication manufactured, distributed, or labeled by Koco Life LLC, Biogenesis Inc., PhytogenX, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

84130-001-10 Sun Shield Body Glow SPF50 DX

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 & evenly 15 minutesbefore 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 from 10 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

84130-000-20 Sunglaze Sheer Body Mist Sunscreen SPF 42

Active ingredients

Avobenzone 3 %
Homosalate 0.5 %
Octisalate 5%
Octocrylene 10%

Purpose

Avobenzone 3 %....................Sunscreen
Homosalate 0.5 %....................Sunscreen
Octisalate 5%....................Sunscreen
Octocrylene 10%....................Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.

Warnings

For external use only

Do not use on damaged or broken skin

Do not spray in eyes. If contact occurs, rinse well with water. If irritation persists, consult a doctor.

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 dispensing. Spray directly onto skin. For Sunscreen use:Apply generously and evenly 15 minutes before sun exposure. Reapply
• After 80 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 & early skin aging. To decrease this risk, regularly use a

sunscreen with a Broad Spectrum SPF value of 15 or higher & 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

Inactive ingredients

Alcohol Denat., C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Diisopropyl Adipate, Sodium Hyaluronate, Tocopherol, Hydrogenated Castor Oil, Tetrahexyldecyl Ascorbate, Ricinus Communis (Castor) Seed Oil, Dicaprylyl Carbonate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance (Parfum), Mica, T-Butyl Alcohol, Tin Oxide, Hexyl Cinnamal, Benzyl Salicylate, Linalool, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides)

Other information

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

Call (858) 252-0099

84130-004-10 Sun Shield On-the-Glow Sheer Stick SPF40

Active ingredients

Avobenzone 3%, Homosalate 10%, Octocrylene 10%, Octisalate 5%

Purpose

Avobenzone 3%, Homosalate 10%, Octocrylene 10%, Octisalate 5%...................Sunscreen

Uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin 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 minutesbefore 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 & early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher & 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

Inactive ingredients

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

Other information

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

Questions/Comments

Call (858) 252-0099

PRINCIPAL DISPLAY PANEL

Kopari

Sun's Out

Fun's Out

Full Size

INGREDIENTS AND APPEARANCE

SUNS OUT FUNS OUT 
avobenzone, homosalate, octisalate, octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-024

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-024-96	1 in 1 KIT; Type 0: Not a Combination Product	12/12/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CONTAINER	30 g
Part 2	1 BOTTLE, PUMP	60 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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	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

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

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	12/12/2025

Part 2 of 3

KOPARI SUNGLAZE SHEER BODY MIST SUNSCREEN SPF42 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Item Code (Source)	NDC: 84130-000
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 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

Inactive Ingredients
Ingredient Name	Strength
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CASTOR OIL (UNII: D5340Y2I9G)
ALCOHOL (UNII: 3K9958V90M)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STANNIC OXIDE (UNII: KM7N50LOS6)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-000-20	60 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	12/12/2025

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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

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

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	12/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/12/2025

Labeler - Koco Life LLC (046650159)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Inc.		069117328	manufacture(84130-024, 84130-004, 84130-001)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	manufacture(84130-000)