St. Moriz Suncare 50+ Body Sunscreen Spf 50

St. Moriz Suncare 50+ Body Sunscreen Spf 50
SPL v1
SPL
SPL Set ID 2c3f1228-5245-a348-e063-6394a90a61d8
Route
TOPICAL
Published
Effective Date 2025-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (40 mg) Homosalate (100 mg) Octocrylene (30 mg) Avobenzone
Inactive Ingredients
Dipotassium Glycyrrhizate .alpha.-tocopherol Acetate, Dl- Silica Propylene Glycol Water Triethanolamine Phenoxyethanol Edetate Disodium Chlorphenesin Butyloctyl Salicylate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Jojoba Oil Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Trehalose C12-20 Alkyl Glucoside C14-22 Alcohols Steareth-21

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-20

Description

Active Ingredients: homosalate 10%, octocrylene 10%, octisalate 4%, avobenzone 3%


Medication Information

Description

Active Ingredients: homosalate 10%, octocrylene 10%, octisalate 4%, avobenzone 3%

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions) decreases risk of skin cancer and early skin aging caused by the sun
Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Warnings
  • For external use only.
  • Do not use on damaged or broken skin
  • When using this product [bullet] keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if [bullet] rash or irritation develops and lasts.
  • Keep out of reach of children, If product is swallowed, get medical help or contact poison control centre right away.
  • To ensure compatibility, we recommend patch testing before first use. In the unlikely event of a negative reaction, discontinue use and consult your medical practitioner.

Directions
  • Apply generously 15 minutes before sun exposure”
  • Reapply [bullet] after 80 minutes of swimming or sweating [bullet] immediately after towel drying [bullet] at least every 2 hours
  • 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 aging. 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
Do Not Use

Do not use on damaged or broken skin

Active Ingredient

Active Ingredients: homosalate 10%, octocrylene 10%, octisalate 4%, avobenzone 3%

Other Information

Protect the product in this container from excessive heat and direct sun. Store below 30 degrees celcius.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butyloctyl Salicylate, C12-20 Alkyl Glucoside, C14-22 Alcohols, Chlorphenesin, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate, Disodium Edta, Fragrance, Phenoxyethanol, Propylene Glycol, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Steareth-21, Tocopheryl Acetate, Trehalose, Triethanolamine, Water

When Using This Product

keep out of eyes. Rinse with water to remove.

St. Moriz Suncare 50+ Body Sunscreen

NDC 85178-2125-1

180 mL / 6.08 fl oz

Principal Display Panel and information panel primary container:


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions) decreases risk of skin cancer and early skin aging caused by the sun
Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Warnings
  • For external use only.
  • Do not use on damaged or broken skin
  • When using this product [bullet] keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if [bullet] rash or irritation develops and lasts.
  • Keep out of reach of children, If product is swallowed, get medical help or contact poison control centre right away.
  • To ensure compatibility, we recommend patch testing before first use. In the unlikely event of a negative reaction, discontinue use and consult your medical practitioner.

Directions
  • Apply generously 15 minutes before sun exposure”
  • Reapply [bullet] after 80 minutes of swimming or sweating [bullet] immediately after towel drying [bullet] at least every 2 hours
  • 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 aging. 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
Do Not Use (Do not use)

Do not use on damaged or broken skin

Active Ingredient

Active Ingredients: homosalate 10%, octocrylene 10%, octisalate 4%, avobenzone 3%

Other Information

Protect the product in this container from excessive heat and direct sun. Store below 30 degrees celcius.

Inactive Ingredients (Inactive ingredients)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butyloctyl Salicylate, C12-20 Alkyl Glucoside, C14-22 Alcohols, Chlorphenesin, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate, Disodium Edta, Fragrance, Phenoxyethanol, Propylene Glycol, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Steareth-21, Tocopheryl Acetate, Trehalose, Triethanolamine, Water

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

St. Moriz Suncare 50+ Body Sunscreen

NDC 85178-2125-1

180 mL / 6.08 fl oz

Principal Display Panel and information panel primary container:


Advanced Ingredient Data


Raw Label Data

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