ULTRA LIGHT INVISIBLE SPF 40 SUNSCREEN- homosalate 8%, octisalate 5.0%, avobenzone 3.0%, octocrylene 4.0% gel

Ultra Light Invisible SPF 40 sunscreen by

Drug Labeling and Warnings

Ultra Light Invisible SPF 40 sunscreen by is a Otc medication manufactured, distributed, or labeled by RK Shea LLC, Inspec Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients                                      Purpose Avobenzone 3%                                         Sunscreen Homosalate 8%                                         Sunscreen Octisalate   5%                                          Sunscreen Octocrylene 4.0%                                       Sunscreen                           

PURPOSE

Uses

· helps prevent sunburn

Warnings For external use only.

Do not useon damaged or broken skin.
When using this product· keep out of eyes . Rinse with water to
remove.
Stop use and ask doctor if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Apply evenly by hand 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 of 15 or higher and other sun protection measures including · limit time in the sun, especially
from 10 a.m. - 2 p.m. · wear a long-sleeved shirts, pants, hats, and sunglasses. · children under 6 months: Ask a doctor.

Other information ·

protect this product from excessive heat and direct sun · may stain fabrics.

Inactive ingredients

Boswellia Serrata Resin Extract
Butyrospermum Parkii (Shea) Butter
Caprylic/Capric Triglyceride
Caprylyl Glycol
Cyclopentasiloxane
Cyclotetrasiloxane
Cyclohexasiloxane
Diatomaceous Earth
Dicaprylyl Carbonate
Dimethicone
Dimethicone Crosspolymer
Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer
Hyaluronic acid, sodium salt
Isododecane
Lecithin
Lithothamnion Calcareum Extract
Mannitol
Meadowfoam Estolide
Microcrystaline Cellulose
Neopentyl Glycol Diheptanoate
Polyester-7
Polymethylsilsesquioxane
Silica
Simmondsia Chinensis (Jojoba) Seed Oil
Tetrahexyldecyl Ascorbate
Tocopheryl Acetate
Zinc Sulfate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA LIGHT INVISIBLE SPF 40 SUNSCREEN 
homosalate 8%, octisalate 5.0%, avobenzone 3.0%, octocrylene 4.0% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84190-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
CYCLOTETRASILOXANE (UNII: CZ227117JE)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
HYALURONIC ACID (UNII: S270N0TRQY)
ISODODECANE (UNII: A8289P68Y2)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
MANNITOL (UNII: 3OWL53L36A)
MEADOWFOAM ESTOLIDE (UNII: 3HH93SL2H9)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYESTER-7 (UNII: 0841698D2F)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICA (UNII: ETJ7Z6XBU4)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE (UNII: 89DS0H96TB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84190-001-02	1 in 1 CARTON	12/01/2025
1		50 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	12/01/2025

Labeler - RK Shea LLC (125023497)

Registrant - Inspec Solutions (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(84190-001)