SPF 30 SUNSCREEN- homosalate 10% octisalate 5% avobenzone 3% spray

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients                     Purpose

Homosalate 10%                          Sunscreen
Octisalate 5%                              Sunscreen
Avobenzone 3%                          Sunscreen

PURPOSE

Uses

Helps prevent sunburn

Directions

Apply evenly to face and neck 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
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
10a.m.– 2p.m. . Wear long-sleeve shirts, pants, hats, and sunglasses.
. Children under 6 months: Ask a doctor.

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 a doctor ifrash occurs.

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Inactive Ingredients

Alcohol Denat.
Aloe Barbadensis Leaf Extract
Ascorbyl Palmitate
Butyloctyl Salicylate
Daucus Carota Sativa (Carrot) Root Extract
Fragrance
Helianthus Annuus (Sunflower) Seed Oil
Mangifera Indica (Mango) Seed Butter
Mineral Oil
Oryza Sativa (Rice) Bran Oil
Phospholipids
Polyester-8
Retinyl Palmitate
Rubus Idaeus (Red Raspberry) Seed Oil
Sodium Hyaluronate
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF 30 SUNSCREEN 
homosalate 10% octisalate 5% avobenzone 3% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85033-003
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 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE (UNII: V5VD430YW9)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DAUCUS CAROTA SATIVA (CARROT) JUICE (UNII: QXF936IX43)
FRAGRANCE ESC 10-740 (UNII: QH92QT9LWR)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
MINERAL OIL (UNII: T5L8T28FGP)
ORYZA SATIVA (RICE) GERM OIL (UNII: D4H5GGS5JF)
BOVINE LUNG PHOSPHOLIPIDS ADULT (UNII: EA3D6UW549)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
RETINYL PALMITATE (UNII: 1D1K0N0VVC)
RASPBERRY SEED OIL (UNII: 9S8867952A)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85033-003-04	117 mL in 1 CAN; Type 0: Not a Combination Product	10/16/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/16/2025

Labeler - Coconut Caliente Costa Rica LLC (119375163)

Registrant - Inspec Solutions (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(85033-003)