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

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.

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
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
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

Description

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

Section 50565-1

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

Do Not Use

Do not use on damaged or broken skin

Active Ingredient

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

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

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.

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
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
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

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.

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%

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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