SPL v3
SPL
SPL Set ID 7cb3bfc3-d957-4ba2-97cf-464073fdbbd7
Route
TOPICAL
Published
Effective Date 2015-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (19.3 mg) Octisalate (48.2 mg) Octocrylene (26.5 mg)
Inactive Ingredients
(c10-c30)alkyl Methacrylate Ester Adenosine Cyclic Phosphate Adenosine Triphosphate Butylated Hydroxytoluene N-butylphthalimide Green Tea Leaf Cetyl Alcohol Coleus Forskohlii Root Oil N,n-dimethyl-2-octadecanamine Edetate Disodium Dextrose Soy Protein Isopropylphthalimide Lycium Barbarum Fruit Methylisothiazolinone Methylparaben Micrococcus Luteus Phenyl Trimethicone Omega-3 Fatty Acids Amino Acids Polyethylene Glycol, Unspecified Polysilicone-15 Potassium Cetyl Phosphate Potassium Hydroxide Propylene Glycol Propylparaben Pyruvic Acid Calcium Saccharomyces Lysate Magnesium Zinc Silicon Dioxide Stearyl Alcohol Styrene Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-04-01

Description

Avobenzone 2 %, Octisalate 5 %, and Octocrylene 1.85 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2 %, Octisalate 5 %, and Octocrylene 1.85 %

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 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 2 %, Octisalate 5 %, and Octocrylene 1.85 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Coleus Forskohlii Root Extract, Disodium EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isopropylphthalimide, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Micrococcus Lysate, Phenoxyethanol, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyethylene, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water (Aqua)

Principal Display Panel  133 Ml  tube Label



CALIFORNIA TAN

CT

15

SUNSCREEN LOTION

Broad Spectrum SPF 15

Water Resistant

(80 Minutes)

CLEANTOUCH™

TECHNOLOGY

4.5 FL Oz (133 mL)


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 60561-8 (60561-8)

For external use only

Purpose

Sunscreen

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 2 %, Octisalate 5 %, and Octocrylene 1.85 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Coleus Forskohlii Root Extract, Disodium EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isopropylphthalimide, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Micrococcus Lysate, Phenoxyethanol, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyethylene, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water (Aqua)

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



CALIFORNIA TAN

CT

15

SUNSCREEN LOTION

Broad Spectrum SPF 15

Water Resistant

(80 Minutes)

CLEANTOUCH™

TECHNOLOGY

4.5 FL Oz (133 mL)


Advanced Ingredient Data


Raw Label Data

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