Shamrock Sun Spf 50 Sunscreen

Shamrock Sun Spf 50 Sunscreen
SPL v1
SPL
SPL Set ID b9c21d5f-ef3d-1ab8-e053-2a95a90a99b9
Route
TOPICAL
Published
Effective Date 2021-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Octocrylene (10 g) Homosalate (3 g) Avobenzone
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Sorbitan Monooleate .alpha.-tocopherol Acetate Polysorbate 20 High Density Polyethylene Alkyl (c12-15) Benzoate Propylene Glycol Phenoxyethanol Ethylhexylglycerin Cocoa Butter Hypromellose, Unspecified Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf Water Edetic Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-01-25
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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.
Dosage and Administration

Directions:

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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.
  • children under 6 months: ask a doctor.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients Water, Propylene Glycol, High Density Polyethylene, C12-15 Alkyl Benzoate, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Fragrance, Sodium Hydroxide, Disodium EDTA, Hydroxypropyl Methylcellulose, Sorbitan Oleate, Tocopheryl Acetate, Ethylhexylglycerin, Theobroma Cacao (Cocoa) Seed Butter

Section 51945-4

SHAMROCK SUN

SUNSCREEN

Broad Spectrum SPF 50

50

Water Resistant (80 Minutes)

32 fl oz (946 mL)

Section 53413-1

Questions?

1-833-286-2789

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredients

Avobenzone 3%, Homosalate 10%, Octislate 5%, Octocrylene 5%

Structured Label Content

Indications and Usage (34067-9)

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.
Dosage and Administration (34068-7)

Directions:

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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.
  • children under 6 months: ask a doctor.
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients Water, Propylene Glycol, High Density Polyethylene, C12-15 Alkyl Benzoate, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Fragrance, Sodium Hydroxide, Disodium EDTA, Hydroxypropyl Methylcellulose, Sorbitan Oleate, Tocopheryl Acetate, Ethylhexylglycerin, Theobroma Cacao (Cocoa) Seed Butter

Section 51945-4 (51945-4)

SHAMROCK SUN

SUNSCREEN

Broad Spectrum SPF 50

50

Water Resistant (80 Minutes)

32 fl oz (946 mL)

Section 53413-1 (53413-1)

Questions?

1-833-286-2789

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Avobenzone 3%, Homosalate 10%, Octislate 5%, Octocrylene 5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:21.495884 · Updated: 2026-03-14T22:59:17.868516