SPL v1
SPL
SPL Set ID 47433a62-91e0-b031-e063-6294a90a0d49
Route
TOPICAL
Published
Effective Date 2022-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Zinc Oxide (7 g) Titanium Dioxide (7.85 g)
Inactive Ingredients
Butylene Glycol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Triethoxycaprylylsilane Caprylic/capric Triglyceride Tangerine Peel Aluminum Hydroxide Phenoxyethanol Ceresin Magnesium Aluminum Silicate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Arbutin 1,2-hexanediol Hippophae Rhamnoides Fruit Ethylhexylglycerin Sodium Hyaluronate Ferrous Oxide Sodium Chloride Sorbitan Sesquioleate Water Synthetic Beeswax Cyclohexasiloxane Cyclopentasiloxane Peg-10 Dimethicone (600 Cst) Ethylhexyl Palmitate Adenosine Dimethicone Stearalkonium Hectorite

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-28

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 damage 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 7.5%

Titanium Dioxide 7.85%

Zinc Oxide 7.0%

Inactive Ingredients

Water, Cyclopentasiloxane, Cyclohexasiloxane, Caprylic/Capric Triglyceride, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Arbutin, Ethylhexyl Palmitate, Dimethicone, Synthetic Beeswax, Sodium Chloride, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Ozokerite, PEG-10 Dimethicone Crosspolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Adenosine, Citrus Depressa Peel Extract, 1,2-Hexanediol, Hippophae Rhamnoides Fruit Extract, Ethylhexylglycerin, Sodium Hyaluronate, Iron Oxides (CI 77492, CI 77491, CI 77499)

Questions Or Comments?

Visit www.purlisse.com.

Principal Display Panel – Youth Glow Vitamin C Cc Cream Sunscreen Spf 50 Medium

pūrlisse

Youth Glow

VITAMIN C

CC

CREAM

SUNSCREEN

SPF 50

vitamin c +

hyaluronic acid

color correcting

brightening

age defying

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 damage 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 7.5%

Titanium Dioxide 7.85%

Zinc Oxide 7.0%

Inactive Ingredients

Water, Cyclopentasiloxane, Cyclohexasiloxane, Caprylic/Capric Triglyceride, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Arbutin, Ethylhexyl Palmitate, Dimethicone, Synthetic Beeswax, Sodium Chloride, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Ozokerite, PEG-10 Dimethicone Crosspolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Adenosine, Citrus Depressa Peel Extract, 1,2-Hexanediol, Hippophae Rhamnoides Fruit Extract, Ethylhexylglycerin, Sodium Hyaluronate, Iron Oxides (CI 77492, CI 77491, CI 77499)

Questions Or Comments? (Questions or comments?)

Visit www.purlisse.com.

Principal Display Panel – Youth Glow Vitamin C Cc Cream Sunscreen Spf 50 Medium (Principal Display Panel – Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Medium)

pūrlisse

Youth Glow

VITAMIN C

CC

CREAM

SUNSCREEN

SPF 50

vitamin c +

hyaluronic acid

color correcting

brightening

age defying

net wt. 1.4 fl. oz. / 40 mL


Advanced Ingredient Data


Raw Label Data

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