Total Defense Repair Broad Spectrum Spf 34 Sunscreen (tinted)-

Total Defense Repair Broad Spectrum Spf 34 Sunscreen (tinted)-
SPL v7
SPL
SPL Set ID 6a996e03-907f-4e6a-b232-0892b86956b0
Route
TOPICAL
Published
Effective Date 2015-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Octisalate (30 mg) Titanium Dioxide (35 mg) Zinc Oxide (80 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Squalane Silicon Dioxide Glycerin Niacinamide Dimethicone, Unspecified Glyceryl Monostearate Peg-100 Monostearate Cetostearyl Alcohol Shea Butter Phenoxyethanol Polyoxyl 20 Cetostearyl Ether Batilol Ferric Oxide Yellow Hydroxyacetophenone Polyhydroxystearic Acid (2300 Mw) .alpha.-tocopherol Acetate Physalis Angulata Whole Butylene Glycol Xanthan Gum Panthenol Alkyl (c12-15) Benzoate Ferric Oxide Red Betaine Ethylhexylglycerin Edetate Disodium Anhydrous Aminomethylpropanol Isostearic Acid Green Tea Leaf Ferrosoferric Oxide Potassium Sorbate Polygonum Aviculare Top Peg-12 Dimethicone (300 Cst) Ubidecarenone Tremella Fuciformis Fruiting Body Melanin Synthetic (tyrosine, Peroxide) Dunaliella Salina Caprylyl Glycol Tocopherol Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-15 Until 2024-06-30

Description

Octinoxate 7.5% Octisalate 3.0% Titanium Dioxide 3.5% Zinc Oxide 8.0%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Description

Octinoxate 7.5% Octisalate 3.0% Titanium Dioxide 3.5% Zinc Oxide 8.0%

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

  • reapply at least every 2 hours and after towel drying, swimming, or sweating to avoid lowering protection

  • Sun Protection Measures UV exposure from 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 the product in this container from excessive heat and direct sun

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

Octinoxate 7.5%

Octisalate 3.0%

Titanium Dioxide 3.5%

Zinc Oxide 8.0%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Squalane, Silica, Glycerin, Niacinamide, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polygonum Aviculare Extract, Physalis Angulata Extract, Dunaliella Salina Extract, Ubiquinone, Camellia Sinensis Leaf Extract, Tremella Fuciformis Sporocarp Extract, Betaine, Melanin, Tocopheryl Acetate, Tocopherol, Hydroxyacetophenone, Batyl Alcohol, C12-15 Alkyl Benzoate, PEG-12 Dimethicone, Panthenol, Butylene Glycol, Ceteareth-20, Polyhydroxystearic Acid, Isostearic Acid, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA, Aminomethyl Propanol, Caprylyl Glycol, Potassium Sorbate, Sorbic Acid, Phenoxyethanol, Iron Oxides (77491,77492,77499)

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 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 Carton Label

NDC 0023-5497-23 

TOTAL DEFENSE

+

REPAIR

TINTED

BROAD SPECTRUM

SPF 34 / PA++++

SUNSCREEN

Net Wt. 2.3 Oz / 65 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

Sunscreen

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure

  • reapply at least every 2 hours and after towel drying, swimming, or sweating to avoid lowering protection

  • Sun Protection Measures UV exposure from 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 the product in this container from excessive heat and direct sun

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

Octinoxate 7.5%

Octisalate 3.0%

Titanium Dioxide 3.5%

Zinc Oxide 8.0%

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Squalane, Silica, Glycerin, Niacinamide, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polygonum Aviculare Extract, Physalis Angulata Extract, Dunaliella Salina Extract, Ubiquinone, Camellia Sinensis Leaf Extract, Tremella Fuciformis Sporocarp Extract, Betaine, Melanin, Tocopheryl Acetate, Tocopherol, Hydroxyacetophenone, Batyl Alcohol, C12-15 Alkyl Benzoate, PEG-12 Dimethicone, Panthenol, Butylene Glycol, Ceteareth-20, Polyhydroxystearic Acid, Isostearic Acid, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA, Aminomethyl Propanol, Caprylyl Glycol, Potassium Sorbate, Sorbic Acid, Phenoxyethanol, Iron Oxides (77491,77492,77499)

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 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 Carton Label (Principal Display Panel - Carton Label)

NDC 0023-5497-23 

TOTAL DEFENSE

+

REPAIR

TINTED

BROAD SPECTRUM

SPF 34 / PA++++

SUNSCREEN

Net Wt. 2.3 Oz / 65 g 


Advanced Ingredient Data


Raw Label Data

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