SPL v2
SPL
SPL Set ID 46e167aa-4259-4547-a626-e6a23ddbc03e
Route
TOPICAL
Published
Effective Date 2015-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (300 g) Homosalate (1000 g) Octisalate (500 g) Octocrylene (275 g)
Inactive Ingredients
Aloe Vera Leaf Butane Propane Cetyl Alcohol Sodium Polyacrylate (8000 Mw) Polysorbate 60 Edetate Disodium Isostearic Acid Methylisothiazolinone Phenoxyethanol Phenyl Trimethicone Polysorbate 20 Propylene Glycol Green Tea Leaf Lycium Barbarum Fruit Stearic Acid Ceteareth-22 Styrene/acrylamide Copolymer (mw 500000) .alpha.-tocopherol Acetate Trolamine Vinylpyrrolidone/hexadecene Copolymer Egg Phospholipids Amino Acids Saccharomyces Lysate Soy Protein Calcium Magnesium Zinc Coleus Forskohlii Root Oil Catalase (micrococcus Luteus) Dextrose Adenosine Cyclic Phosphate Pyruvic Acid Adenosine Triphosphate Quaternium-15 Methylparaben Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-12-30

Description

Avobenzone 3 %, Homosalate 10%, Octisalate 5 %, and Octocrylene 2.75 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3 %, Homosalate 10%, Octisalate 5 %, and Octocrylene 2.75 %

Uses
  • helps prevent sunburn
  • if use as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove. Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120°F

Section 50570-1

Do not use on damaged or broken skin

Section 53413-1

Questions or comments?

Call toll free 1-800-SUNCARE

Section 60561-8

For external use only

Warnings

Directions
  • apply liberally and spread evenly by hand 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 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: Ask a doctor
Other Information
  • protect this product from exessive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration
Active Ingredients

Avobenzone 3 %, Homosalate 10%, Octisalate 5 %, and Octocrylene 2.75 %

Inactive Ingredients

Adenosine Cyclic Phesphate, Adenosine Triphosphate, Aloe Barbadensis Leaf Juice, Camelllia Sinensis (Green Tea) Leaf Extract, Ceteareth-20, Cetearyl Alcohol, Coleus Forskohlii Root Extract, Disodium EDTA, EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isostearic Acid, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Methylparaben, Micrococcus Lysate, Phenoxyethanol, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyperfluoroethoxymethoxy Difluoroethyl PEG Phosphate, Polysorbate 20, Polysorbate 60, Propane, Propylene Glycol, Pyruvic Acid, Quaternium-15, Saccharomyces/Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces/Magnesium Ferment, Saccharomyces/Zinc Ferment, Sodium Polyacrylate, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethanolamine, VP/Hexadecene, Water (Aqua)

Principal Display Panel  170 g Can label

California Tan

CT

30

Body

Mousse

Sunscreen Mousse

Broad Spectrum SPF 30

Water Resistant

(80 Minutes)

OIL FREE

Net Wt. 6 oz (170g)


Structured Label Content

Uses
  • helps prevent sunburn
  • if use as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove. Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120°F

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 53413-1 (53413-1)

Questions or comments?

Call toll free 1-800-SUNCARE

Section 60561-8 (60561-8)

For external use only

Purpose

Sunscreen

Warnings

Directions
  • apply liberally and spread evenly by hand 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 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: Ask a doctor
Other Information
  • protect this product from exessive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration
Active Ingredients (Active ingredients)

Avobenzone 3 %, Homosalate 10%, Octisalate 5 %, and Octocrylene 2.75 %

Inactive Ingredients

Adenosine Cyclic Phesphate, Adenosine Triphosphate, Aloe Barbadensis Leaf Juice, Camelllia Sinensis (Green Tea) Leaf Extract, Ceteareth-20, Cetearyl Alcohol, Coleus Forskohlii Root Extract, Disodium EDTA, EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isostearic Acid, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Methylparaben, Micrococcus Lysate, Phenoxyethanol, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyperfluoroethoxymethoxy Difluoroethyl PEG Phosphate, Polysorbate 20, Polysorbate 60, Propane, Propylene Glycol, Pyruvic Acid, Quaternium-15, Saccharomyces/Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces/Magnesium Ferment, Saccharomyces/Zinc Ferment, Sodium Polyacrylate, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethanolamine, VP/Hexadecene, Water (Aqua)

Principal Display Panel  170 g Can label (PRINCIPAL DISPLAY PANEL - 170 g Can Label)

California Tan

CT

30

Body

Mousse

Sunscreen Mousse

Broad Spectrum SPF 30

Water Resistant

(80 Minutes)

OIL FREE

Net Wt. 6 oz (170g)


Advanced Ingredient Data


Raw Label Data

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