PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46- octinoxate, zinc oxide lotion

PHACE BIOACTIVE SOOTHING DAY Plus PRIMER BROAD-SPECTRUM SPF 46 by

Drug Labeling and Warnings

PHACE BIOACTIVE SOOTHING DAY Plus PRIMER BROAD-SPECTRUM SPF 46 by is a Otc medication manufactured, distributed, or labeled by Vara International Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octinoxate  7.5%
Zinc Oxide  9.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the skin
  

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 occurs.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center immediately.

Directions

• apply liberally to face and neck 15 minutes before sun exposure
• use a water-resistant sunscreen if swimming or sweating
• reapply 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 value of SPF 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, and sunglasses
• children under 6 months:  Ask a physician
  

Inactive Ingredients

Tocopherol, Aloe Barbadensis Leaf Juice, Aqua/Water/Eau, Ascorbic Acid, Butylene Glycol, Caprylic/Capric Triglyceride, Cocamidopropyl Betaine, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Ethylhexylglycerin, Hyaluronic Acid, Hydrolyzed Silk Proteins, Isohexadecane, Lactic Acid, Lecithin, Acetyl Glucosamine, Niacinamide, Phenoxyethanol, Polysorbate 20, Polysorbate 80, Punica Granatum Extract, Sodium Polyacryloyldimethyltaurate Copolymer, Superoxide Dismutase, VAccinium Angustifolium (Blueberry) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Propanediol.

Other Information

protect this product from excessive heat and direct sun

Questions or comments?

Toll free 1-800-942-1498 or visit www.phacebioactive.com

PHACE BIOACTIVE SOOTHING DAY CREAM + PRIMER BROAD-SPECTRUM SPF 46 50ml (65121-682-03)

INGREDIENTS AND APPEARANCE

PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46  
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70960-682
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYALURONIC ACID (UNII: S270N0TRQY)
ISOHEXADECANE (UNII: 918X1OUF1E)
LACTIC ACID (UNII: 33X04XA5AT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70960-682-03	1 in 1 PACKAGE	09/13/2016
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/19/2014

Labeler - Vara International Inc. (080371258)