SPL v1
SPL
SPL Set ID 47325530-b097-db9a-e063-6294a90a335d
Route
TOPICAL
Published
Effective Date 2020-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (7.98 g) Octinoxate (6.5 g) Zinc Oxide (3.5 g)
Inactive Ingredients
Dimethicone Cyclopentasiloxane Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Schisandra Chinensis Fruit Gardenia Jasminoides Fruit Magnesium Aluminum Silicate Peg-10 Dimethicone (600 Cst) Crataegus Laevigata Fruit Sorbitan Sesquioleate Water Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Ferrous Oxide Caprylic/capric Triglyceride Beeswax Cyclotetrasiloxane Lycium Chinense Fruit Phenoxyethanol Bacillus Polyfermenticus Ceresin Butylene Glycol Sodium Chloride Cornus Officinalis Fruit Stearalkonium Hectorite 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-06

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

Use helps prevent sunburn

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

Directions

For sunscreen use:

  • 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. to 2 p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor
Other Information

Protect this product from excessive heat and direct sun light.

Active Ingredients

Octinoxate 6.5%

Titanium Dioxide 7.98%

Zinc Oxide 3.5%

Inactive Ingredients

Water, Cyclopentasiloxane, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Dimethicone, Sodium Chloride, Beeswax, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Phenoxyethanol, Ozokerite, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-10 Dimethicone Crosspolymer, Cyclotetrasiloxane, 1,2-Hexanediol, Bacillus Ferment, Schisandra Chinensis Fruit Extract, Lycium Chinense Fruit Extract, Crataegus Oxyacantha Fruit Extract, Gardenia Jasminoides Fruit Extract, Cornus Officinalis Fruit Extract. May Contain: Iron Oxides (CI 77491, CI77492, CI 77499)

Questions Or Comments?

Visit www.purlisse.com or call weekdays at (424)777-0321.

Principal Display Panel Perfect Glow Bb Cream Sunscreen Spf 30 40 Ml – Light Warm

pūrlisse

Perfect Glow

BB

CREAM

SUNSCREEN

SPF 30

oil free

moisturizing

natural-looking coverage

matte meets glowy finish

for all skin types,

even sensitive

net wt. 1.4 fl. oz / 40 mL


Structured Label Content

Uses

Use helps prevent sunburn

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

  • 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. to 2 p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor
Other Information

Protect this product from excessive heat and direct sun light.

Active Ingredients

Octinoxate 6.5%

Titanium Dioxide 7.98%

Zinc Oxide 3.5%

Inactive Ingredients

Water, Cyclopentasiloxane, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Dimethicone, Sodium Chloride, Beeswax, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Phenoxyethanol, Ozokerite, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-10 Dimethicone Crosspolymer, Cyclotetrasiloxane, 1,2-Hexanediol, Bacillus Ferment, Schisandra Chinensis Fruit Extract, Lycium Chinense Fruit Extract, Crataegus Oxyacantha Fruit Extract, Gardenia Jasminoides Fruit Extract, Cornus Officinalis Fruit Extract. May Contain: Iron Oxides (CI 77491, CI77492, CI 77499)

Questions Or Comments? (Questions or comments?)

Visit www.purlisse.com or call weekdays at (424)777-0321.

Principal Display Panel Perfect Glow Bb Cream Sunscreen Spf 30 40 Ml – Light Warm (Principal Display Panel - Perfect Glow BB Cream Sunscreen SPF 30 40 mL – Light Warm)

pūrlisse

Perfect Glow

BB

CREAM

SUNSCREEN

SPF 30

oil free

moisturizing

natural-looking coverage

matte meets glowy finish

for all skin types,

even sensitive

net wt. 1.4 fl. oz / 40 mL


Advanced Ingredient Data


Raw Label Data

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