SeneGence SeneSun Hydrating Facial Sunscreen SPF 20

SeneGence SeneSun Hydrating Facial Sunscreen by

Drug Labeling and Warnings

SeneGence SeneSun Hydrating Facial Sunscreen by is a Otc medication manufactured, distributed, or labeled by SGII, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SENEGENCE SENESUN HYDRATING FACIAL SUNSCREEN SPF 20- avobenzone, homosalate, octisalate, octocrylene liquid 
SGII, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SeneGence SeneSun Hydrating Facial Sunscreen SPF 20

Active Ingredient

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 6%

Purpose

Sunscreen

• For external use only.

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

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

Uses

• Helps prevent sunburn.

Directions

• Following cleansing, squeeze a dime size amount of product onto fingers and gently massage into skin for an immediate boost of moisture, plus SPF protection.

For Sunscreen use:

• ​Apply generously evenly 15 minutes before sun exposure
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• Children under 6 months. Ask a doctor.

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 long-sleeved shirts, pants, hats and sunglasses.

Inactive ingredients Water/Aqua/Eau, Polymethylsilsesquioxane, Propanediol, Cetearyl Alcohol, Orchid (Orchis Mascula) Flower Extract, Seaweed (Corallina Officinalis) Extract, Cucumber (Cucumis Sativus) Extract, Kelp (Laminaria Digitata) Extract, Yeast (Saccharomyces Cerevisiae) Extract, Aloe Vera (Aloe Barbadensis) Leaf Juice, Sodium Acetylated Hyaluronate, Sodium Hyaluronate, Sodium Hyaluronate Crosspolymer-2, Hydrolyzed Sodium Hyaluronate, Xylitylglucoside, Anhydroxylitol, Xylitol, Panthenol, Retinyl Palmitate, Tocopheryl Acetate, Behenyl Alcohol, Potassium Cetyl Phosphate, Polysilicone-11, Ceteth-10 Phosphate, Dicetyl Phosphate, Xanthan Gum, Ethylhexylglycerin, Sclerotium Gum, Lecithin, Pentylene Glycol, Pullulan, Glucose, Trisodium Ethylenediamine Disuccinate, Silica, Butylene Glycol, Laureth-12, Urea*, Glucosamine HCl, Phenoxyethanol.

*Synthetic

SENEGENCE SENESUN HYDRATING FACIAL SUNSCREEN  SPF 20
avobenzone, homosalate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72644-630
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
CUCUMBER (UNII: YY7C30VXJT)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PANTHENOL (UNII: WV9CM0O67Z)
LAURETH-12 (UNII: OAH19558U1)
XYLITOL (UNII: VCQ006KQ1E)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PULLULAN (UNII: 8ZQ0AYU1TT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
YEAST (UNII: 3NY3SM6B8U)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72644-630-03	86 mL in 1 TUBE; Type 0: Not a Combination Product	08/12/2020	01/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/12/2020	01/10/2023

Labeler - SGII, Inc (070096792)

Revised: 1/2023

Document Id: f26d08ac-aec2-b38f-e053-2995a90a1c37

34390-5

Set id: acb7ee1b-c425-18f8-e053-2a95a90af8ac

Version: 4

Effective Time: 20230116