SUMMER GELEE SPF-4- homosalate, octisalate gel

SUMMER GELEE SPF-4 by

Drug Labeling and Warnings

SUMMER GELEE SPF-4 by is a Otc medication manufactured, distributed, or labeled by SUMMER GELEE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Homosalate 2.00%, Octisalate 2.00%

Purpose

Sunscreen

Uses:

Helps prevent sunburn.

• Higher SPF gives more sunburn protection. 
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early 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 or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

Apply liberally 15 minutes before sun exposure and as needed.

• Children under 6 months of age: ask a doctor.
• Reapply at least every 2 hours. 
• Use a water-resistant sunscreen if swimming or sweating.
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am-2pm.
• Wear long-sleeved shirts, pants, hats, & sunglasses.

Other Information:

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

Inactive Ingredients:

Cinnamomum Cassia Oil, Hydrogenated Vegetable Oil, Iron Oxides (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Tocopheryl Acetate (Vitamin E), D&C Red #17.

Package Labeling:

INGREDIENTS AND APPEARANCE

SUMMER GELEE SPF-4 
homosalate, octisalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84281-476
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHINESE CINNAMON OIL (UNII: A4WO0626T5)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
D&C RED NO. 17 (UNII: ND733RX3JN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84281-476-00	92.26 mL in 1 TUBE; Type 0: Not a Combination Product	05/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/06/2024

Labeler - SUMMER GELEE LLC (119209761)