st. moriz suncare 30+ body sunscreen

st. moriz suncare 30+ body sunscreen
SPL v1
SPL
SPL Set ID 2c3e2f61-12aa-78b4-e063-6394a90a38c1
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 (80 mg) octocrylene (50 mg) avobenzone (30 mg)
Inactive Ingredients
xanthan gum propylene glycol glycerin stearic acid water triethanolamine cyclopentasiloxane lauric acid palmitic acid chlorphenesin butyloctyl salicylate glycereth-20 glyceryl stearate isosteareth-20 dimethicone crosspolymer isoceteth-20 myristic acid phenoxyethanol edetate disodium acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-20

Description

Active Ingredients: homosalate 8%, octocrylene 5%, 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, chlorphenesin, cyclopentasiloxane, dimethicone crosspolymer, disodium edta, fragrance, glycereth-20, glycerin, glyceryl stearate, isoceteth-20, isosteareth-20, lauric/myristic/palmitic/stearic glycerides, phenoxyethanol, propylene glycol, triethanolamine, xanthan gum, water

Description

Active Ingredients: homosalate 8%, octocrylene 5%, 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 8%, octocrylene 5%, octisalate 4%, avobenzone 3%

When Using This Product

keep out of eyes. Rinse with water to remove.

St. Moriz Suncare 30+ Body Sunscreen

NDC85178-2025-1

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, chlorphenesin, cyclopentasiloxane, dimethicone crosspolymer, disodium edta, fragrance, glycereth-20, glycerin, glyceryl stearate, isoceteth-20, isosteareth-20, lauric/myristic/palmitic/stearic glycerides, phenoxyethanol, propylene glycol, triethanolamine, xanthan gum, 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 8%, octocrylene 5%, octisalate 4%, avobenzone 3%

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

St. Moriz Suncare 30+ Body Sunscreen

NDC85178-2025-1

180 mL /  6.08 fl oz

Principal Display Panel and information panel primary container:


Advanced Ingredient Data


Raw Label Data

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