FDA.reportPublic FDA data

BIOSOLIS Sun Milk SPF 30

Manufacturer
Pro Vera SA
Effective date
2022-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:45:40

Label at a glance#

ProductBIOSOLIS Sun Milk SPF 30
Active ingredientZINC 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 sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure  Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating  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, especia...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18.8%

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 sun.

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 if

OTC - STOP USE SECTION

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 right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure 
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating 
  • 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 of age: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS LEAF JUICE*, PONGAMIA GLABRA SEED OIL*, CAPRYLIC/CAPRIC TRIGLYCERIDE, DICAPRYLYL CARBONATE, PROPANEDIOL,
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-3 DIISOSTEARATE, POLYHYDROXYSTEARIC ACID, BENZYL ALCOHOL, GLYCERYL DIBEHENATE, SODIUM CHLORIDE, BISABOLOL, TRIBEHENIN, GLYCERYL BEHENATE, DEHYDROACETIC ACID, TOCOPHEROL, AQUA, PARFUM, CITRONELLOL, LIMONENE, LINALOOL.

Questions or comments?

OTC - QUESTIONS SECTION

info@biosolis.info or Call
Adverse Event Reporting: 1-866-8539427

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelBoxBox

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61296-01261296-012-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
KARUM SEED OIL62160PU6FJIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PROPANEDIOL5965N8W85TIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
BENZYL ALCOHOLLKG8494WBHIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
SODIUM CHLORIDE451W47IQ8XIACT
LEVOMENOL24WE03BX2TIACT
TRIBEHENIN8OC9U7TQZ0IACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
DEHYDROACETIC ACID2KAG279R6RIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
ZINC OXIDESOI2LOH54ZACTIM

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
eedf8c4a-32dd-562a-e053-2995a90a1240b8691c99-eb8f-3305-e053-2995a90a94882022-12-02WarningsExact identifier
spl id: eedf8c4a-32dd-562a-e053-2995a90a1240
spl set id: b8691c99-eb8f-3305-e053-2995a90a9488

Reported adverse events (FAERS/openFDA)#

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