BIOSOLIS Sunscreen Broadspectrum SPF50 KIDS

BIOSOLIS Sunscreen Broadspectrum SPF50 KIDS by

Drug Labeling and Warnings

BIOSOLIS Sunscreen Broadspectrum SPF50 KIDS by is a Otc medication manufactured, distributed, or labeled by Pro Vera SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOSOLIS SUNSCREEN BROADSPECTRUM SPF50 KIDS- titanium dioxide, zinc oxide cream 
Pro Vera SA

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BIOSOLIS Sunscreen Broadspectrum SPF50 KIDS

Drug Facts

Active ingredients

Titanium dioxide 10%

Zinc oxide 13.5%

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 sun.

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 right away

Directions

• apply liberally 15 minutes before sun exposure
• 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 aBroad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 3 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• reapply
• after 40 minutes swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

ALOE VERA LEAF JUICE*, ALUMINUM HYDROXIDE,BENZYL ALCOHOL, BISABOLOL*, CAPRYLIC/CAPRICTRIGLYCERIDE, DEHYDROACETIC ACID, DICAPRYLYLCARBONATE, KARANJA TREE SEED EXTRACT,POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE,POLYGLYCERYL-3 DIISOSTEARATE,POLYHYDROXYSTEARIC ACID, PROPANEDIOL,SESAME OIL*, SODIUM CHLORIDE, STEARIC ACID,TOCOPHEROL, WATER.

Questions or comments?

1-866-853-9427

Package Labeling:61296-014-00

BIOSOLIS SUNSCREEN BROADSPECTRUM SPF50 KIDS 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61296-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	135 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LEVOMENOL (UNII: 24WE03BX2T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
SESAME OIL (UNII: QX10HYY4QV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61296-014-00	1 in 1 BOX	01/07/2022	04/30/2025
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/07/2022	04/30/2025

Labeler - Pro Vera SA (375713286)

Registrant - Pro Vera SA (375713286)

Revised: 1/2024

Document Id: 0e993203-3e8d-5fbd-e063-6294a90a0636

34390-5

Set id: cc80a2d1-147d-4f0f-9cd4-47683034a639

Version: 4

Effective Time: 20240110