Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 279a5214-79b2-44e9-b003-378d0b992395
Route
TOPICAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (50 mg) Zinc Oxide (60 mg)
Inactive Ingredients
Water Cyclomethicone 5 Dimethicone Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Butylene Glycol Aluminum Hydroxide Sodium Chloride Peg-9 Polydimethylsiloxyethyl Dimethicone Phenoxyethanol Ferric Oxide Yellow Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Sodium Citrate, Unspecified Form Peg/ppg-18/18 Dimethicone Ferric Oxide Red Ethylhexylglycerin Camellia Oleifera Leaf Triethoxycaprylylsilane .alpha.-tocopherol Acetate Ferrosoferric Oxide Stearic Acid Caffeine Dimethicone/peg-10/15 Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-16

Description

Titanium Dioxide 5.0% Zinc Oxide 6.0%

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Description

Titanium Dioxide 5.0% Zinc Oxide 6.0%

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

Directions
  • Apply liberally 15 minutes before sun exposure

  • Use a water resistant sunscreen if swimming or sweating

  • Reapply at least every 2 hours

  • Sun Protection Measures Spending time in the sun increases the risk of skin cancer, premature skin aging and other skin damage. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a.m.-2 p.m., and wearing protective clothing

  • Children under 6 months: Ask a doctor
Do Not Use

on damaged or broken skin

Other Information
  • Protect this product from excessive heat and direct sun

  • Store at room temperature 15° - 30°C (59° - 86°F)
Active Ingredients

Titanium Dioxide 5.0%

Zinc Oxide 6.0%

Inactive Ingredients

Water, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Aluminum Hydroxide, Dimethicone/PEG-10/15 Cross polymer, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Caffeine, Camellia Oleifera Leaf Extract, Tocopheryl Acetate, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxvsilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Stearic Acid, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)

Questions Or Comments?

www.skinmedica.com 

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if skin rash occurs

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel Tube Label

SkinMedica®

ESSENTIAL

DEFENSE

MINERAL SHIELD™

BROAD SPECTRUM

SPF 32

SUNSCREEN

POST-PROCEDURE &

SENSITIVE SKIN

TINTED

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g

Principal Display Panel Carton Label

SkinMedica®

ESSENTIAL

DEFENSE

MINERAL SHIELD™

BROAD SPECTRUM

SPF 32

SUNSCREEN

POST PROCEDURE &

SENSITIVE SKIN

TINTED

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g


Structured Label Content

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
Purpose

Sunscreen

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure

  • Use a water resistant sunscreen if swimming or sweating

  • Reapply at least every 2 hours

  • Sun Protection Measures Spending time in the sun increases the risk of skin cancer, premature skin aging and other skin damage. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a.m.-2 p.m., and wearing protective clothing

  • Children under 6 months: Ask a doctor
Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)
  • Protect this product from excessive heat and direct sun

  • Store at room temperature 15° - 30°C (59° - 86°F)
Active Ingredients (Active ingredients)

Titanium Dioxide 5.0%

Zinc Oxide 6.0%

Inactive Ingredients (Inactive ingredients)

Water, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Aluminum Hydroxide, Dimethicone/PEG-10/15 Cross polymer, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Caffeine, Camellia Oleifera Leaf Extract, Tocopheryl Acetate, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxvsilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Stearic Acid, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)

Questions Or Comments? (Questions or comments?)

www.skinmedica.com 

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if skin rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel Tube Label (Principal Display Panel - Tube Label)

SkinMedica®

ESSENTIAL

DEFENSE

MINERAL SHIELD™

BROAD SPECTRUM

SPF 32

SUNSCREEN

POST-PROCEDURE &

SENSITIVE SKIN

TINTED

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g

Principal Display Panel Carton Label (Principal Display Panel - Carton Label)

SkinMedica®

ESSENTIAL

DEFENSE

MINERAL SHIELD™

BROAD SPECTRUM

SPF 32

SUNSCREEN

POST PROCEDURE &

SENSITIVE SKIN

TINTED

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g


Advanced Ingredient Data


Raw Label Data

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