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

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 5.0% Zinc Oxide 6.0%


Medication Information

Warnings

For external use only

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

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

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

Description

Titanium Dioxide 5.0% Zinc Oxide 6.0%

Do Not Use

on damaged or broken skin

Active Ingredients

Titanium Dioxide 5.0%

Zinc Oxide 6.0%

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

Warnings

For external use only

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

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

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

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Titanium Dioxide 5.0%

Zinc Oxide 6.0%

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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