SPL v4
SPL
SPL Set ID 8ea7a7d5-4c8b-402f-91a3-165567a484e4
Route
TOPICAL
Published
Effective Date 2014-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (29.9 mg) Homosalate (99.8 mg) Octisalate (49.9 mg) Octocrylene (27.5 mg) Oxybenzone (19.9 mg)
Inactive Ingredients
Polysilicone-15 Potassium Cetyl Phosphate Potassium Hydroxide Propylene Glycol Propylparaben Pyruvic Acid Calcium Saccharomyces Lysate Magnesium Zinc Silicon Dioxide Stearyl Alcohol Styrene Water Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Adenosine Cyclic Phosphate Adenosine Triphosphate Butylated Hydroxytoluene 3-butylphthalide Green Tea Leaf Cetyl Alcohol Plectranthus Barbatus Root Edetate Disodium Dextrose Soy Protein Isopropylphthalimide Lycium Barbarum Fruit Methylisothiazolinone Methylparaben Phenyl Trimethicone High Density Polyethylene Omega-3 Fatty Acids Amino Acids

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-04-04

Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.7 %, and Oxybenzone 2 %


Medication Information

Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.7 %, and Oxybenzone 2 %

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
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.

Section 50570-1

Do not use on damaged or broken skin.

Section 53413-1

Questions or Comments?

Call toll free 1-800-SUNCARE

Section 55105-1

Purpose

Sunscreen

Section 60561-8

For external use only

Warnings

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 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 excesive heat and direct sun

Active Ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.7 %, and Oxybenzone 2 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylated Hydroxytoluene, Butylphthalimide, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Coelus Forskohlii Extract, Disodium EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isopropylphthalimide, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Methylparaben, Micrococcus Lysate, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyethylene, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water (Aqua)

Principal Display Panel  133 ml  tube Label

CALIFORNIA TAN

CT

45

SUNSCREEN LOTION

Broad Spectrum SPF 45

Water Resistant

(80 Minutes)

CLEANTOUCH

TECHNOLOGY

133 mL / 4.5 Fl Oz


Structured Label Content

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
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.

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 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

For external use only

Warnings

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 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 (Other information)
  • protect this product from excesive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.7 %, and Oxybenzone 2 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylated Hydroxytoluene, Butylphthalimide, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Coelus Forskohlii Extract, Disodium EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isopropylphthalimide, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Methylparaben, Micrococcus Lysate, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyethylene, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water (Aqua)

Principal Display Panel  133 ml  tube Label (PRINCIPAL DISPLAY PANEL - 133 mL  Tube Label)

CALIFORNIA TAN

CT

45

SUNSCREEN LOTION

Broad Spectrum SPF 45

Water Resistant

(80 Minutes)

CLEANTOUCH

TECHNOLOGY

133 mL / 4.5 Fl Oz


Advanced Ingredient Data


Raw Label Data

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