SUMMER FACE SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene liquid

Summer Face Sunscreen SPF 50 by

Drug Labeling and Warnings

Summer Face Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by SUMMER GELEE LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3.00%
Homosalate 10.00%
Octisalate 5.00%
Octocrylene 7.5%

Purpose

Sunscreen

Uses:

Helps prevent sunburn. Higher SPF gives moresunburn protection. Retains SPF after 80 minutes of swimming or sweating. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin 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: 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 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 heatand direct sun.

Inactive Ingredients:

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Brassica Napus (Rapeseeds) Glycerides, Butylene Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Methicone, Cetearyl Olivate, Decyl Glucoside, Dodecane, Ethylhexylglycerin, Glycerin, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Oryza Sativa (Rice) Bran Extract, Phenoxyethanol, Polyacrylate Crosspolymer-6, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Rosmarinus Officinalis (Rosemary) Extract, Sodium Stearoyl Glutamate, Sorbitan Olivate, Sorbitan Stearate, Tetrasodium EDTA, Tocopherol, Water (Aqua)

Package Labeling:

INGREDIENTS AND APPEARANCE

SUMMER FACE SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84281-893
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DODECANE (UNII: 11A386X1QH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
RICE BRAN (UNII: R60QEP13IC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPANEDIOL (UNII: 5965N8W85T)
ROSEMARY (UNII: IJ67X351P9)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SORBITAN STEARATE (UNII: NVZ4I0H58X)
TETRASODIUM EDTA (UNII: MP1J8420LU)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84281-893-00	79.78 mL in 1 TUBE; Type 0: Not a Combination Product	09/04/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/04/2025

Labeler - SUMMER GELEE LLC (119209761)

Registrant - Pure Source, LLC (080354456)