Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 6fe0f50d-21b5-4d06-a119-ef80def51e20
Route
TOPICAL
Published
Effective Date 2013-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (10 g) Avobenzone (3 g) Octisalate (5 g) Homosalate (10 1)
Inactive Ingredients
Water Ethylhexyl Palmitate Sorbitol Diethylhexyl Syringylidenemalonate Aloe Vera Leaf Trolamine Glyceryl Monostearate Peg-100 Stearate Tricaprin Edetate Disodium Oleth-3 Tocopherol Sodium Ascorbyl Phosphate Benzyl Alcohol Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-09

Description

Avobenzone 3.0%, Homosalate 10.0% Octisalate 5.0% Octocrylene 10.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0% Octisalate 5.0% Octocrylene 10.0%

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 the sun.



Warnings

For external use only

Do not use on damaged skin or broken skin

Directions:


  • 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 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 a.m.- 2 p.m
  • wear long -sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age:Ask a doctor

Other Information

protect this product from excessive heat and direct sun



Active Ingredients

Avobenzone 3.0%,

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 10.0%





Inactive Ingredients

water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucoase Distearate, Diethylhexyl Syringyldenemalonate, Acrylates/C12-22 Alkyl methcrylate, Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG_100 Stearate, Caprylic/Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.



Principal Display Panel

PETER

ISLAND

Sunscreen Lotion

30

BROAD SPECTRUM

SPF 30

Moisturizing

Vitamion E and Aloe

UVA/UVB Protection

Water Resistant (80 minutes)

8 FL. OZ. (236 mL)



When Using This Product

keep out of eyes. Rinse with water to remove.



Stop Use and Ask A Doctor

if rash occurs



Keep Out of Reach of Children

if product is swallowed, get medical help or contact a Poison Control Center right away.

  • May stain some fabrics.



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 the sun.



Purpose

Sunscreen

Warnings

For external use only

Do not use on damaged skin or broken skin

Directions: (DIRECTIONS:)


  • 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 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 a.m.- 2 p.m
  • wear long -sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age:Ask a doctor

Other Information

protect this product from excessive heat and direct sun



Active Ingredients (Active ingredients)

Avobenzone 3.0%,

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 10.0%





Inactive Ingredients

water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucoase Distearate, Diethylhexyl Syringyldenemalonate, Acrylates/C12-22 Alkyl methcrylate, Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG_100 Stearate, Caprylic/Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.



Principal Display Panel

PETER

ISLAND

Sunscreen Lotion

30

BROAD SPECTRUM

SPF 30

Moisturizing

Vitamion E and Aloe

UVA/UVB Protection

Water Resistant (80 minutes)

8 FL. OZ. (236 mL)



When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.



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

if rash occurs



Keep Out of Reach of Children (keep out of reach of children)

if product is swallowed, get medical help or contact a Poison Control Center right away.

  • May stain some fabrics.



Advanced Ingredient Data


Raw Label Data

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