SPL v6
SPL
SPL Set ID eb381ad7-34c7-4c2f-b862-d2a16b212816
Route
TOPICAL
Published
Effective Date 2012-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Octinoxate (7.25 g) Octocrylene (9.75 g) Oxybenzone (3 g)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Aloe Vera Leaf Isododecane Phenoxyethanol Edetate Sodium Carbomer Copolymer Type A Trolamine Sorbitan Monooleate Alpha-tocopherol Acetate Vitamin A Palmitate Selenicereus Grandiflorus Flower

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-04-28

Description

Avobenzone 2.0%, Octinoxate 7.25%, Octocrylene 9.75%, Oxybenzone 3.0%

Purpose

Purpose...............Sunscreen


Medication Information

Purpose

Purpose...............Sunscreen

Description

Avobenzone 2.0%, Octinoxate 7.25%, Octocrylene 9.75%, Oxybenzone 3.0%

Uses
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • High protection against sunburn and tanning
  • Retains SPF after 40 minutes of activity in the water or sweating

Section 50565-1
  • Keep out of reach of children.
Section 51945-4

Place holder text.

Warnings
  • For external use only. When using this product
  • Keep out of eyes
  • Rinse with warm water to remove.  Stop use and ask doctor if
  • rash or irritation develops and lasts
Directions
  • Apply liberally 30 minutes before sun exposure
  • Children under 6 months of age consult a doctor
  • Reapply as needed or after towel drying, swimming or sweating

Inactive Ingredients

Water (Aqua), C12-15 Alkyl Benzoate, Acrylates/C12-22 Alkyl Methacrylate Copolymer (Waterproofing), Aloe Barbadensis (Aloe Vera) Leaf Juice, Isododecane, Phenoxyethanol (Preservative), Fragrance (Parfum), Tetrasodium EDTA, Carbomer, Triethanolamine, Sorbitan Oleate (Plant Derived), Tocopheryl Acetate (Vitamin E Acetate), Retinyl Palmitate (Vitamin A Palmitate), Cereus Grandiflorus (Cactus) Flower Extract, Methylisothiazolinone.



Questions or comments: 1-800-411-8801 . patrickssunscreen.com



Active Ingredients.............

Avobenzone 2.0%, Octinoxate 7.25%, Octocrylene 9.75%, Oxybenzone 3.0%


Structured Label Content

Uses
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • High protection against sunburn and tanning
  • Retains SPF after 40 minutes of activity in the water or sweating

Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51945-4 (51945-4)

Place holder text.

Purpose

Purpose...............Sunscreen

Warnings
  • For external use only. When using this product
  • Keep out of eyes
  • Rinse with warm water to remove.  Stop use and ask doctor if
  • rash or irritation develops and lasts
Directions
  • Apply liberally 30 minutes before sun exposure
  • Children under 6 months of age consult a doctor
  • Reapply as needed or after towel drying, swimming or sweating

Inactive Ingredients (Inactive ingredients)

Water (Aqua), C12-15 Alkyl Benzoate, Acrylates/C12-22 Alkyl Methacrylate Copolymer (Waterproofing), Aloe Barbadensis (Aloe Vera) Leaf Juice, Isododecane, Phenoxyethanol (Preservative), Fragrance (Parfum), Tetrasodium EDTA, Carbomer, Triethanolamine, Sorbitan Oleate (Plant Derived), Tocopheryl Acetate (Vitamin E Acetate), Retinyl Palmitate (Vitamin A Palmitate), Cereus Grandiflorus (Cactus) Flower Extract, Methylisothiazolinone.



Questions or comments: 1-800-411-8801 . patrickssunscreen.com



Active Ingredients............. (Active ingredients.............)

Avobenzone 2.0%, Octinoxate 7.25%, Octocrylene 9.75%, Oxybenzone 3.0%


Advanced Ingredient Data


Raw Label Data

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