FDA.reportPublic FDA data

BIOSOLIS Sun Milk SPF 50 Kids

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 50 Kids
Active ingredientTITANIUM DIOXIDE, 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 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, especially ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 10%
Zinc Oxide 15.5%

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

DICAPRYLYL CARBONATE, ALOE BARBADENSIS LEAF JUICE*, PONGAMIA GLABRA SEED OIL*, DIETHYL SEBACATE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, PROPANEDIOL, STEARIC ACID, POLYGLYCERYL-3 DIISOSTEARATE, ALUMINUM HYDROXIDE, BRASSICA CAMPESTRIS OIL*, TALC, BENZYL ALCOHOL, BISABOLOL*, SODIUM CHLORIDE, DEHYDROACETIC ACID, TOCOPHEROL, PARFUM, AQUA, CITRAL, 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

Outer LabelOuter LabelInner LabelInner Label

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61296-01061296-010-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
DICAPRYLYL CARBONATE609A3V1SUAIACT
ALOE VERA LEAFZY81Z83H0XIACT
KARUM SEED OIL62160PU6FJIACT
DIETHYL SEBACATEI41B9FJK6VIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
PROPANEDIOL5965N8W85TIACT
STEARIC ACID4ELV7Z65APIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BRASSICA RAPA SUBSP. OLEIFERA OILN4G8379626IACT
TALC7SEV7J4R1UIACT
BENZYL ALCOHOLLKG8494WBHIACT
LEVOMENOL24WE03BX2TIACT
SODIUM CHLORIDE451W47IQ8XIACT
DEHYDROACETIC ACID2KAG279R6RIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
CITRALT7EU0O9VPPIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
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
eedad2ce-69c5-7a56-e053-2995a90adebfb78b495d-a289-572b-e053-2a95a90a82582022-12-02WarningsExact identifier
spl id: eedad2ce-69c5-7a56-e053-2995a90adebf
spl set id: b78b495d-a289-572b-e053-2a95a90a8258

Reported adverse events (FAERS/openFDA)#

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