VIVANT DAY TREATMENT SPF 15- octinoxate 7.50% octisalate 5.00% lotion

Vivant Day Treatment SPF 15 by

Drug Labeling and Warnings

Vivant Day Treatment SPF 15 by is a Otc medication manufactured, distributed, or labeled by Vivant Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose
Octinoxate 7.5%.......................................................................Sunscreen
Octisalate 5.0%........................................................................Sunscreen

PURPOSE

Sunscreen

INDICATIONS & USAGE

Uses helps prevent sunburn

WARNINGS

Warnings
For external use only
Do not useon damaged or broken skin

When using this product

Keep out of eyes. Rinse with water to remove.

Stop Use and ask a doctor

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children

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

Directions

Directions
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours

• Children under 6 months of age: 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-sleeve shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun.

Inactive ingredients

Water, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Emulsifying Wax, Caprylic/Capric Triglyceride, Octyldodecanol, Dimethicone, Aloe Barbadensis Leaf Juice, Saccharomyces/Zinc Ferment, Carbomer, Polysorbate 20, Titanium Dioxide, Disodium EDTA, Sodium Hydroxide, Potassium Sorbate, Ethylhexylglycerin, Phenoxyethanol

Day Treatment Lotion SPF 15

INGREDIENTS AND APPEARANCE

VIVANT DAY TREATMENT SPF 15 
octinoxate 7.50% octisalate 5.00% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63750-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ACRYLIC ACID (UNII: J94PBK7X8S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG-60 STEARATE (UNII: 7TB32G765E)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
OCTYLDODECANOL (UNII: 461N1O614Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63750-015-03	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2024

Labeler - Vivant Pharmaceuticals, LLC (782696814)

Establishment
Name	Address	ID/FEI	Business Operations
Vivant Pharmaceuticals, LLC		782696814	manufacture(63750-015)