Sun on the Run Kit

Manufacturer
Koco Life LLC | Biogenesis Inc. | Cosmax Usa, Corporation
Effective date
2024-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:39

Label at a glance#

ProductSun on the Run Kit
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure4 sections

Label contents#

Full prescribing information#

84130-001-10 Sun Shield Body Glow SPF50 DX

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

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

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

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

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

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes
Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call (858) 252-0099

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Questions/Comments

OTC - QUESTIONS SECTION

Call (858) 252-0099

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

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

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 4%

Purpose

OTC - PURPOSE SECTION

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

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

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

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

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

• For external use only

OTC - DO NOT USE SECTION

• Do not use on damaged or broken skin

OTC - DO NOT USE SECTION

• Do not use on damaged or broken skin

OTC - WHEN USING SECTION

• When using this product keep out of eyes• Rinse with water to remove

OTC - STOP USE SECTION

• Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children

• If product is swallowed, get medicalhelp or contact a Poison ControlCenter right away

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call (858) 252-0099

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84130-001-10Sun on the Run Kit30 mL in 1 BOTTLE, PUMPGEL30 mL50 mg in 1mL1
84130-004-10Sun on the Run Kit30 g in 1 CONTAINERSTICK30 g5 g in 100g1
84130-006-21Sun on the Run Kit5 mL in 1 TUBECREAM5 mL50 mg in 1mL1
84130-009-98Sun on the Run Kit1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84130-001SUN ON THE RUN KIT (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [KOCO LIFE LLC]1Current NDC20240704_1c351485-0998-e308-e063-6394a90a9ee6.zip
84130-004SUN ON THE RUN KIT (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [KOCO LIFE LLC]1Current NDC20240704_1c351485-0998-e308-e063-6394a90a9ee6.zip
84130-006SUN ON THE RUN KIT (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [KOCO LIFE LLC]1Current NDC20240704_1c351485-0998-e308-e063-6394a90a9ee6.zip
84130-009SUN ON THE RUN KIT (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [KOCO LIFE LLC]1Current NDC, 4 package rows20240704_1c351485-0998-e308-e063-6394a90a9ee6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 66 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Suns Out Funs OutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC46040acf-512e-c867-e063-6294a90ac2202025-12-15WarningsExact identifier
ndc (package): 84130-004-10
ndc (package): 84130-001-10
ndc11 (package): 84130000410
ndc11 (package): 84130000110
Sun Voyage KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC2732a8d2-6f56-c088-e063-6294a90af3082024-11-18WarningsExact identifier
ndc (package): 84130-004-10
ndc (package): 84130-001-10
ndc11 (package): 84130000410
ndc11 (package): 84130000110
Sun Shield Soft Glow Daily Face SPF30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEKoco Life LLC1c312800-4068-399e-e063-6394a90aec022024-07-01WarningsExact identifier
ndc (package): 84130-006-21
ndc (product): 84130-006
ndc11 (package): 84130000621
Sun on the Run KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c351485-0998-e308-e063-6394a90a9ee62024-07-01WarningsExact identifier
ndc (package): 84130-006-21
ndc (package): 84130-004-10
ndc (package): 84130-009-98
ndc (package): 84130-001-10
ndc (product): 84130-009
ndc11 (package): 84130000410
ndc11 (package): 84130000621
ndc11 (package): 84130000998
ndc11 (package): 84130000110
spl id: 1c351485-0999-e308-e063-6394a90a9ee6
spl set id: 1c351485-0998-e308-e063-6394a90a9ee6
Sun Shield On-the-Glow Sheer Stick SPF40AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c237d5a-1663-e9a1-e063-6294a90a6a242024-06-30WarningsExact identifier
ndc (package): 84130-004-10
ndc (product): 84130-004
ndc11 (package): 84130000410
Sun Shield Body Glow SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEKoco Life LLC180aa4d5-6dac-e658-e063-6394a90a32872024-06-28WarningsExact identifier
ndc (package): 84130-001-10
ndc (product): 84130-001
ndc11 (package): 84130000110
Sun Essentials SPF Duo KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c329b86-664e-de1f-e063-6394a90a7c232024-06-28WarningsExact identifier
ndc (package): 84130-001-10
ndc11 (package): 84130000110

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.