soléo®

soléo®
SPL v6
SPL
SPL Set ID 59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b
Route
topical
Published
Effective Date 2025-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (223 mg)
Inactive Ingredients
grape seed oil sunflower oil medium-chain triglycerides candelilla wax yellow wax macadamia oil theobroma grandiflorum seed butter green tea leaf chamaemelum nobile flower soybean lecithin safflower oil cucumber .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2007-01-20

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings
  • For external use only
Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides high protection against sunburn
  • retains SPF after 80 minutes of activity in the water
Purpose

Sunscreen

Directions
  • Squeeze cream and shake tube well before use
  • apply liberally 20 minutes before sun exposure and as needed
  • store below 30°C/86°F
Inactive Ingredients

Beeswax, candelilla wax, caprylic/capric triglyceride (plant sourced), coconut extract, cucumber extract, cupuacu butter, grapeseed oil, green tea leaf extract, lecithin, macadamia oil, roman chamomile extract, safflower oil, sunflower oil, vegetable oil, vitamin E (natural)

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children
Section 50567-7
  • When using this product keep out of eyes, rinse with water to remove
Active Ingredients (usa/aus)

Zinc oxide 22.3% w/w

Principal Display Panel 80 G Tube Carton

MULTI

AWARD

WINNING

#1

SUNSCREEN

soléo®

organics

ORIGINAL FORMULA

HIGH PERFORMANCE

• SE FORMULA •

SE FORMULA

ALL NATURAL

SUNSCREEN

SPF

30

3hour

very water

resistant*

UV-A

UV-B

Broad Spectrum

80g/2.8 oz e AUST-L 116246


Structured Label Content

Warnings
  • For external use only
Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides high protection against sunburn
  • retains SPF after 80 minutes of activity in the water
Purpose

Sunscreen

Directions
  • Squeeze cream and shake tube well before use
  • apply liberally 20 minutes before sun exposure and as needed
  • store below 30°C/86°F
Inactive Ingredients

Beeswax, candelilla wax, caprylic/capric triglyceride (plant sourced), coconut extract, cucumber extract, cupuacu butter, grapeseed oil, green tea leaf extract, lecithin, macadamia oil, roman chamomile extract, safflower oil, sunflower oil, vegetable oil, vitamin E (natural)

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children
Section 50567-7 (50567-7)
  • When using this product keep out of eyes, rinse with water to remove
Active Ingredients (usa/aus) (Active Ingredients (USA/AUS))

Zinc oxide 22.3% w/w

Principal Display Panel 80 G Tube Carton (PRINCIPAL DISPLAY PANEL - 80 g Tube Carton)

MULTI

AWARD

WINNING

#1

SUNSCREEN

soléo®

organics

ORIGINAL FORMULA

HIGH PERFORMANCE

• SE FORMULA •

SE FORMULA

ALL NATURAL

SUNSCREEN

SPF

30

3hour

very water

resistant*

UV-A

UV-B

Broad Spectrum

80g/2.8 oz e AUST-L 116246


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)