Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 9a0a1a55-7184-48f4-80bf-b94bdd8d6815
Route
TOPICAL
Published
Effective Date 2013-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (13 g) Octisalate (5 g) Octocrylene (7 g) Oxybenzone (4 g)
Inactive Ingredients
Water Sorbitol Stearic Acid Trolamine Aluminum Starch Octenylsuccinate Benzyl Alcohol Sorbitan Isostearate Dimethicone Methylparaben Tocopherol Propylparaben Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-12

Description

Avobenzone 3.0% Homosalate 13.0% Octisalate    5.0% Octocrylene 7.0% Oxybenzone 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen



Description

Avobenzone 3.0% Homosalate 13.0% Octisalate    5.0% Octocrylene 7.0% Oxybenzone 4.0%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures ( see Directions) decrease the risk of skin cancer and early skin aging caused by sun.

Section 50565-1

Keep out of the reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

May stain some fabrics.



Warnings

For external use only

Directions
  • apply literally 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 increase your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:



  • Limit time in the sun, especially from 10 am - 2 pm
  • Wear long sleeves shirts, pants, hats and sunglasses
  • children under 6 month of age: Ask a doctor


Other Information

protect this product from excessive heat and direct sun



Active Ingredients

Avobenzone 3.0%

Homosalate 13.0%

Octisalate    5.0%

Octocrylene 7.0%

Oxybenzone 4.0%



Inactive Ingredients

Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.



Principal Display Panel

Publix

sunscreen lotion

50 SPF

MOISTURIZING

VERY WATER RESISTANT

Broad Spectrum Protection

8 FL OZ(237 mL)





When Using This Product
  • keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs




Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures ( see Directions) decrease the risk of skin cancer and early skin aging caused by sun.

Section 50565-1 (50565-1)

Keep out of the reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

May stain some fabrics.



Purpose

Sunscreen



Warnings

For external use only

Directions
  • apply literally 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 increase your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:



  • Limit time in the sun, especially from 10 am - 2 pm
  • Wear long sleeves shirts, pants, hats and sunglasses
  • children under 6 month of age: Ask a doctor


Other Information (Other information)

protect this product from excessive heat and direct sun



Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 13.0%

Octisalate    5.0%

Octocrylene 7.0%

Oxybenzone 4.0%



Inactive Ingredients (Inactive ingredients)

Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.



Principal Display Panel

Publix

sunscreen lotion

50 SPF

MOISTURIZING

VERY WATER RESISTANT

Broad Spectrum Protection

8 FL OZ(237 mL)





When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)