SENEGENCE MICROBIOME DEFENSE SUNSCREEN DAYTIME MOISTURIZER SPF15- zinc oxide, octisalate lotion

SeneGence Microbiome Defense Sunscreen Daytime Moisturizer SPF15 by

Drug Labeling and Warnings

SeneGence Microbiome Defense Sunscreen Daytime Moisturizer SPF15 by is a Otc medication manufactured, distributed, or labeled by SGII, INC, TCI Co.,Ltd.-BioCosme PABP BRANCH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide (6%)

Octisalate (5%)

Purpose

Zinc Oxide (6%).............Sunscreen

Octisalate (5%)..............Sunscreen

Uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions)

Warnings

For external use only. Flammable.

When using this product keep out of eyes. Rinse with water to remove.

Do not use on damaged or broken skin.

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.

Directions

for sunscreen use:

• Apply liberally 15 minutes before sun exposure
• Children under 6 months of age: ask a doctor
• Sun Protection Measures: Spending time in the sun increases your 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

Other Information

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

Inactive Ingredients

Aqua/Water/Eau, Butylene Glycol, Butyloctyl Salicylate, Isoamyl Laurate, Cetearyl Olivate, Caprylic/Capric Glycerides, Helianthus Annuus (Sunflower) Seed Wax, Lactobacillus Ferment, Vegetable Oil, Sorbitan Olivate, Polyglyceryl-6 Stearate, Coco-Caprylate/Caprate, Glycerin, Saccharomyces Ferment Filtrate, Hydroxyacetophenone, 1,2-Hexanediol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Aronia Melanocarpa Fruit Extract, Polyglyceryl-6 Polyhydroxystearate, Cetyl Alcohol, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-6 Behenate, Simmondsia Chinensis (Jojoba) Seed Oil, Lecithin, Xanthan Gum, Tetrahexyldecyl AScorbate, Tocopherol, Ascorbyl Palmitate, Bisabolol, O-Cymen-5-Ol, Sargassum Glaucescens Extract, Curcuma Longa (Turmeric) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Panthenol, Calanthe Discolor (Ebine) Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Hydrolyzed Opuntia Ficus-Indica (Prickly Pear) Flower Extract, Sodium Hyaluronate, Citric Acid, Gluconolactone, Caprylyl Glycol, Sodium Benzoate, Calcium Gluconate, Laminaria Digitata (Kelp) Extract, Saccharomyces Cerevisiae (Yeast) Extract, Orchis Mascula (Orchid) Flower Extract, Phenoxyethanol, Urea, Glucosamine HCl.

PRINCIPAL DISPLAY PANEL

SeneGence

Microbiome

Defense

Sunscreen Daytime Moisturizer

Broad Spectrum SPF 15

SenePlex+

with Orchid Stem Cells

1.7 fl oz/50 mL

INGREDIENTS AND APPEARANCE

SENEGENCE MICROBIOME DEFENSE SUNSCREEN DAYTIME MOISTURIZER SPF15 
zinc oxide, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72644-638
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TURMERIC (UNII: 856YO1Z64F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
ARONIA MELANOCARPA FRUIT (UNII: S935718Z2Q)
TOCOPHEROL (UNII: R0ZB2556P8)
ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
XANTHAN GUM (UNII: TTV12P4NEE)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CORN OIL (UNII: 8470G57WFM)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CETYL ALCOHOL (UNII: 936JST6JCN)
JOJOBA OIL (UNII: 724GKU717M)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WATER (UNII: 059QF0KO0R)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
UREA (UNII: 8W8T17847W)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-5 CAPRYLIC/CAPRIC GLYCERIDES (UNII: S0SPK283TZ)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PANTHENOL (UNII: WV9CM0O67Z)
OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72644-638-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/10/2024
2	NDC: 72644-638-02	2 mL in 1 PACKET; Type 0: Not a Combination Product	05/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/10/2024

Labeler - SGII, INC (070096792)

Establishment
Name	Address	ID/FEI	Business Operations
TCI Co.,Ltd.-BioCosme PABP BRANCH		657732201	manufacture(72644-638)