SeneGence SeneSun Sunscreen by SGII, Inc SeneGence SeneSun SPF 30

Drug Details [pdf]

SENEGENCE SENESUN SUNSCREEN SPF 30- homosalate, octinoxate, octisalate, oxybenzone spray
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 SPF 30

Active Ingredient

Homosalate 6.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

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

Spray generously and spread evenly by hand 15 minutes before sun exposure
Hold container 4 to 6 inches from the skin to apply
Do not spray directly into face. Spray on hands then apply to face.
Do not apply in windy conditions
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 value 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
Children under 6 months: ask a doctor.

Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Algae (Laminaria Digitata) Extract, Aloe Vera (Aloe Barbadensis) Leaf Juice, Amyl Cinnamal, Benzyl Benzoate, BHT, Butylparaben, C12-15 Alkyl Benzoate, Citral, Citronellol, Dimethicone, Ethylhexyl Palmitate, Ethylparaben, Fragrance/Parfum, Geraniol, Glucosamine HCl, Isobutylparaben, Limonene, Linalool, Methylparaben, Orchid (Orchis Morio) Flower Extract, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, Retinyl Palmitate, Seaweed (Corallina Officinalis) Extract, Sodium PCA, Tetrasodium EDTA, Tocopherol, Tocopheryl Acetate, Triacontanyl PVP, Triethanolamine, Urea, Water/Aqua/Eau, Yeast (Saccharomyces Cerevisiae) Extract.

SGSSSPF30

SENEGENCE SENESUN SUNSCREEN SPF 30
homosalate, octinoxate, octisalate, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72644-632
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 mg in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mg in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
LINALOOL, (+)- (UNII: F4VNO44C09)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
YEAST (UNII: 3NY3SM6B8U)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CORALLINA OFFICINALIS (UNII: 4004498D06)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 72644-632-04	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/12/2020	08/12/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/12/2020	08/12/2022

Labeler - SGII, Inc (070096792)

Revised: 1/2023

Document Id: f155143d-2860-6ef0-e053-2995a90add17

Set id: ad0e6de8-fc4d-5f71-e053-2995a90a5548

Version: 4

Effective Time: 20230102