total defense repair broad spectrum spf 34 sunscreen- octinoxate, octisalate and zinc oxide lotion 

total defense repair broad spectrum spf 34 sunscreen- octinoxate, octisalate and zinc oxide lotion 
SPL v8
SPL
SPL Set ID 9c9e9d2a-64b1-4b53-81ad-0b347f89a93e
Route
topical
Published
Effective Date 2015-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (75 mg) octisalate (30 mg) zinc oxide (80 mg)
Inactive Ingredients
water medium-chain triglycerides silicon dioxide squalane glycerin niacinamide dimethicone, unspecified glyceryl monostearate peg-100 monostearate cetostearyl alcohol shea butter polygonum aviculare top physalis angulata whole dunaliella salina ubidecarenone green tea leaf tremella fuciformis fruiting body betaine melanin synthetic (tyrosine, peroxide) alpha-tocopherol acetate tocopherol hydroxyacetophenone batilol alkyl (c12-15) benzoate panthenol butylene glycol polyoxyl 20 cetostearyl ether polyhydroxystearic acid (2300 mw) isostearic acid xanthan gum ethylhexylglycerin edetate disodium anhydrous aminomethylpropanol caprylyl glycol potassium sorbate sorbic acid phenoxyethanol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-06-15

Purpose

Sunscreen Sunscreen Sunscreen

Description

Octinoxate 7.5% Octisalate 3.0% Zinc Oxide 8.0%


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

Sunscreen

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
Other Information
  • protect the product in this container from excessive heat and direct sun

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

Water, Caprylic/Capric Triglyceride, Silica, Squalane, 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, Panthenol, Butylene Glycol, Ceteareth-20, Polyhydroxystearic Acid, Isostearic Acid, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA, Aminomethyl Propanol, Caprylyl Glycol, Potassium Sorbate, Sorbic Acid, Phenoxyethanol

Description

Octinoxate 7.5% Octisalate 3.0% Zinc Oxide 8.0%

Do Not Use

on damaged or broken skin

Active Ingredients

Octinoxate 7.5%

Octisalate 3.0%

Zinc Oxide 8.0%

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 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 0023-5494-23

TOTAL DEFENSE

+

REPAIR

BROAD SPECTRUM

SPF 34 / PA++++


SUNSCREEN


Net Wt. 2.3 Oz. / 65 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

Sunscreen

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
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)
Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Silica, Squalane, 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, Panthenol, Butylene Glycol, Ceteareth-20, Polyhydroxystearic Acid, Isostearic Acid, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA, Aminomethyl Propanol, Caprylyl Glycol, Potassium Sorbate, Sorbic Acid, Phenoxyethanol

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Octinoxate 7.5%

Octisalate 3.0%

Zinc Oxide 8.0%

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 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 0023-5494-23

TOTAL DEFENSE

+

REPAIR

BROAD SPECTRUM

SPF 34 / PA++++


SUNSCREEN


Net Wt. 2.3 Oz. / 65 g 


Advanced Ingredient Data


Raw Label Data

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