SUN ON THE RUN KIT- avobenzone, homosalate, octocrylene, octisalate kit

Sun on the Run Kit by

Drug Labeling and Warnings

Sun on the Run Kit by is a Otc medication manufactured, distributed, or labeled by Koco Life LLC, Biogenesis Inc., Cosmax Usa, Corporation. 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

84130-004-10 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

84130-006-21 Sun Shield Soft Glow Daily Face SPF30 DX

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 4%

Purpose

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

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

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

Octocrylene 4%.....................Sunscreen

Uses

Helps prevent sunburn

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

Warnings

For external use only

Do not use on damaged or broken skin

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 medicalhelp or contact a Poison ControlCenter right away

Directions

For Sunscreen use:

Apply generously and evenly15 minutes before sun exposure.

REAPPLY:

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 doctor

Inactive ingredients

Isododecane, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Methicone, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica, Titanium Dioxide (Cl 77891), Tocopheryl Acetate, Silica, Tin Oxide, Tocopherol.

Other information

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

Questions or comments?

Call (858) 252-0099

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN ON THE RUN KIT 
avobenzone, homosalate, octocrylene, octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-009

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-009-98	1 in 1 KIT; Type 0: Not a Combination Product	07/01/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CONTAINER	30 g
Part 2	1 BOTTLE, PUMP	30 mL
Part 3	1 TUBE	5 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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

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

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	07/01/2024

Part 2 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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MACADAMIA OIL (UNII: 515610SU8C)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
COCONUT OIL (UNII: Q9L0O73W7L)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LINALOOL, (+)- (UNII: F4VNO44C09)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
AVOCADO OIL (UNII: 6VNO72PFC1)
HIBISCUS SABDARIFFA SEED OIL (UNII: G2X0304IX1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)

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	07/01/2024

Part 3 of 3

SUN SHIELD SOFT GLOW DAILY FACE SPF30 
homosalate, octisalate, octocrylene, avobenzone cream

Product Information
Item Code (Source)	NDC: 84130-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
MICA (UNII: V8A1AW0880)
STANNOUS OXIDE (UNII: JB2MV9I3LS)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-006-21	5 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 Drug	M020	07/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/01/2024

Labeler - Koco Life LLC (046650159)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Inc.		069117328	manufacture(84130-001, 84130-004, 84130-009)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax Usa, Corporation		010990210	manufacture(84130-006, 84130-009)