FDA.reportPublic FDA data

PHACE BIOACTIVE SOOTHING DAY CREAM + PRIMER BROAD-SPECTRUM SPF 46

Manufacturer
Vara International Inc.
Effective date
2017-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:19:52

Label at a glance#

ProductPHACE BIOACTIVE SOOTHING DAY Plus PRIMER BROAD-SPECTRUM SPF 46
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure8 sections

Indications and 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

Dosage and administration

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 th...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate  7.5%
Zinc Oxide  9.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes, Rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Soothing Day Cream LabelSoothing Day Cream Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70960-68270960-682-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOCOPHEROLR0ZB2556P8IACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 4CZ227117JEIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYALURONIC ACIDS270N0TRQYIACT
ISOHEXADECANE918X1OUF1EIACT
LACTIC ACID33X04XA5ATIACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 806OZP39ZG8HIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
LOWBUSH BLUEBERRYG90PX41VP0IACT
VITIS VINIFERA SEEDC34U15ICXAIACT
PROPANEDIOL5965N8W85TIACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0749bd93-cd63-1f61-e063-6394a90acf5a59347627-6a11-4cb7-bcca-ff654d2f74ac2023-10-09WarningsExact identifier
spl set id: 59347627-6a11-4cb7-bcca-ff654d2f74ac

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.