SUN ESSENTIALS SPF DUO KIT- avobenzone, homosalate, octocrylene, octisalate kit

Sun Essentials SPF Duo Kit by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 e xternal 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

PRINCIPAL DISPLAY PANEL

Kopari

Sun Shield Body Glow

Sunscreen SPF 50 DUO

Endless Glow, Applies Clear, Absorbs Seamlessly

INGREDIENTS AND APPEARANCE

SUN ESSENTIALS SPF DUO KIT 
avobenzone, homosalate, octocrylene, octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-008

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-008-99	1 in 1 KIT; Type 0: Not a Combination Product	06/28/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PUMP	30 mL
Part 2	1 BOTTLE, PUMP	150 mL

Part 1 of 2

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

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

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	06/28/2024

Part 2 of 2

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-001-50	150 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	06/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/28/2024

Labeler - Koco Life LLC (046650159)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Inc.		069117328	manufacture(84130-008, 84130-001)