Dynamic Resurfacing

Dynamic Resurfacing
SPL v7
SPL
SPL Set ID fc64720c-060c-4f33-8c76-96456fac270d
Route
TOPICAL
Published
Effective Date 2017-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (10 mg) Octinoxate (5 mg) Octocrylene
Inactive Ingredients
Water Coco-caprylate Glycerin Medium-chain Triglycerides Cetyl Alcohol Isostearyl Alcohol Butylene Glycol Raspberry Seed Oil Phenoxyethanol .alpha.-tocopherol Acetate Chlorphenesin Melissa Officinalis Leaf Propylene Glycol Sodium Stearoyl Glutamate Docosanol Ethylcellulose, Unspecified Lecithin, Soybean Xanthan Gum Shea Butter Tocopherol Papain Borage Seed Oil Sodium Dehydroacetate Hydrogenated Castor Oil Stearyl Alcohol Euphrasia Stricta Mimosa Tenuiflora Bark Biosaccharide Gum-1 Citric Acid Monohydrate Codium Tomentosum Ecklonia Cava Gelidium Cartilagineum Edetate Disodium Sodium Hydroxide Sargassum Fusiforme Myrtus Communis Leaf Potassium Sorbate Sodium Benzoate Subtilisin Fu Ling Citrus Aurantium Leafy Twig Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-05

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
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 50567-7

When using this product,

  • keep out of eyes. Rinse with water to remove.
Warnings

For external use only

Directions
  • apply liberally and evenly 15 minutes before sun exposure and as needed
  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. 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. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
Do Not Use
  • on damaged or broken skin
Questions?

US T: 1-855-235-3647

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

Avobenzone 1.0% }

Octinoxate 1.0% }

Octocrylene 0.5% }

Inactive Ingredients

Water, Coco-Caprylate, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Isostearyl Alcohol, Butylene Glycol, Butylene Glycol Cocoate, Rubus Idaeus (Raspberry) Seed Oil, Phenoxyethanol, Tocopheryl Acetate, Carbomer, Chlorphenesin, Melissa Officinalis Leaf Extract, Propylene Glycol, Sodium Stearoyl Glutamate, Behenyl Alcohol, Ethylcellulose, Lecithin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Tocopherol, Papain, Borago Officinalis Seed Oil, Fragrance, Disodium EDTA, Sodium Hydroxide, Sodium Dehydroacetate, Hydrogenated Castor Oil, Stearyl Alcohol, Euphrasia Officinalis Extract, Mimosa Tenuiflora Bark Extract, Protease, Biosaccharide Gum-1, Citric Acid, Codium Tomentosum Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Myrtus Communis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Subtilisin, Poria Cocos Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil.

Stop Use and Ask A Doctor If
  • rash occurs
Principal Display Panel 50 Ml Jar Carton

ANTI-AGEING

ELEMIS

DYNAMIC RESURFACING



DAY CREAM SPF 30

Skin smoothing day cream



Broad Spectrum SPF 30 | Sunscreen

  • For uneven, dull skin
  • Tri – Enzymes, Poria Cocos, Raspberry Seed oil
  • Renews, smoothes, hydrates

50 ml e 1.6 US fl.oz.


Structured Label Content

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
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 50567-7 (50567-7)

When using this product,

  • keep out of eyes. Rinse with water to remove.
Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally and evenly 15 minutes before sun exposure and as needed
  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. 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. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
Do Not Use (Do not use)
  • on damaged or broken skin
Questions?

US T: 1-855-235-3647

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Active Ingredients (Active ingredients)

Avobenzone 1.0% }

Octinoxate 1.0% }

Octocrylene 0.5% }

Inactive Ingredients (Inactive ingredients)

Water, Coco-Caprylate, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Isostearyl Alcohol, Butylene Glycol, Butylene Glycol Cocoate, Rubus Idaeus (Raspberry) Seed Oil, Phenoxyethanol, Tocopheryl Acetate, Carbomer, Chlorphenesin, Melissa Officinalis Leaf Extract, Propylene Glycol, Sodium Stearoyl Glutamate, Behenyl Alcohol, Ethylcellulose, Lecithin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Tocopherol, Papain, Borago Officinalis Seed Oil, Fragrance, Disodium EDTA, Sodium Hydroxide, Sodium Dehydroacetate, Hydrogenated Castor Oil, Stearyl Alcohol, Euphrasia Officinalis Extract, Mimosa Tenuiflora Bark Extract, Protease, Biosaccharide Gum-1, Citric Acid, Codium Tomentosum Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Myrtus Communis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Subtilisin, Poria Cocos Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs
Principal Display Panel 50 Ml Jar Carton (PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton)

ANTI-AGEING

ELEMIS

DYNAMIC RESURFACING



DAY CREAM SPF 30

Skin smoothing day cream



Broad Spectrum SPF 30 | Sunscreen

  • For uneven, dull skin
  • Tri – Enzymes, Poria Cocos, Raspberry Seed oil
  • Renews, smoothes, hydrates

50 ml e 1.6 US fl.oz.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)