SPL v3
SPL
SPL Set ID 88a37b3e-3e17-4c7e-be72-980769694d54
Route
TOPICAL
Published
Effective Date 2014-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (16 mg) Octisalate (40.3 mg) Octocrylene (22.2 mg)
Inactive Ingredients
Diethylhexyl 2,6-naphthalate Propylene Glycol Water Lycium Barbarum Fruit Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Green Tea Leaf Alcohol Adenosine Triphosphate Pyruvic Acid Adenosine Cyclic Phosphate Dextrose Omega-3 Fatty Acids Saccharomyces Lysate Dibutyl Maleate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-28

Description

Avobenzone 2 %, Octisalate 5 %, and Octocrylene 2.75 %


Medication Information

Description

Avobenzone 2 %, Octisalate 5 %, and Octocrylene 2.75 %

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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120 0F

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

Directions
  • spray liberally  and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in well-ventilated area
  • 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
  • avoid spraing on fabrics - could cause discoloration
Active Ingredients

Avobenzone 2 %, Octisalate 5 %, and Octocrylene 2.75 %

Inactive Ingredients

Adenosine Cyclic Phosphate, Adenosine Triphosphate, Camellia Sinensis (Green Tea) Leaf Extract, Coelus Forskohlii Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Lycium Barbarum (Goji Berry) Fruit Extract, Micrococcus Lysate, Phospholipids, Plant Amino Acids, Polyester-8, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Propylene Glycol, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Alcohol Denat., VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water (Aqua)

Principal Display Panel  150 Ml Can Label

CALIFORNIA TAN

CT 15

SUNSCREEN SPRAY

Broad Spectrum SPF 15

Water Resistant

(80 Minutes)

OIL FREE

150 mL/ 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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120 0F

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

Directions
  • spray liberally  and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in well-ventilated area
  • 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
  • avoid spraing on fabrics - could cause discoloration
Active Ingredients (Active ingredients)

Avobenzone 2 %, Octisalate 5 %, and Octocrylene 2.75 %

Inactive Ingredients

Adenosine Cyclic Phosphate, Adenosine Triphosphate, Camellia Sinensis (Green Tea) Leaf Extract, Coelus Forskohlii Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Lycium Barbarum (Goji Berry) Fruit Extract, Micrococcus Lysate, Phospholipids, Plant Amino Acids, Polyester-8, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Propylene Glycol, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Alcohol Denat., VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water (Aqua)

Principal Display Panel  150 Ml Can Label (PRINCIPAL DISPLAY PANEL - 150 mL Can Label)

CALIFORNIA TAN

CT 15

SUNSCREEN SPRAY

Broad Spectrum SPF 15

Water Resistant

(80 Minutes)

OIL FREE

150 mL/ 5 Fl Oz


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)