Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID d30fd00e-12da-4db9-bb77-5f6c81f0022c
Route
TOPICAL
Published
Effective Date 2016-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene
Inactive Ingredients
Alcohol Isobutane Isododecane Diisopropyl Adipate Caprylyl Glycol Methyl Dihydroabietate Ascorbyl Palmitate .alpha.-tocopherol Acetate Mineral Oil Panthenol Water Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-03

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

Purpose

Sunscreen


Medication Information

Purpose


Sunscreen





Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

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

Warnings

For external use only

Flammable: Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 1200F. Do not use in the presence of a flame or spark. Keep away from sources of ignition-No smoking.

Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions
  • hold container 4-6 inches from the skin to apply
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Do not spray directly on 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.-2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor.
Do Not Use

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Ascorbyl Palmitate, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract.

Principle Display Label

NDC:  11822-1820-4

daylogic

SPORT CONTINUOUS SPRAY

SUNSCREEN

BROAD SPECTRUM

SPF 50+

UVA/UVB PROTECTION

WATER RESISTANT

(80 MINUTES)

NON-GREASY

QUICK AND EVEN COVERAGE

50+

NET WT 6 OZ (170g)











When Using This Product
  • Keep away from face to avoid breathing it

  • Keep out of eyes.  Rinse with water to remove.

Stop Use and Ask A Doctor

is rash occurs

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

  • May stain some fabrics


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

Purpose


Sunscreen





Warnings

For external use only

Flammable: Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 1200F. Do not use in the presence of a flame or spark. Keep away from sources of ignition-No smoking.

Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions
  • hold container 4-6 inches from the skin to apply
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Do not spray directly on 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.-2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor.
Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Ascorbyl Palmitate, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract.

Principle Display Label

NDC:  11822-1820-4

daylogic

SPORT CONTINUOUS SPRAY

SUNSCREEN

BROAD SPECTRUM

SPF 50+

UVA/UVB PROTECTION

WATER RESISTANT

(80 MINUTES)

NON-GREASY

QUICK AND EVEN COVERAGE

50+

NET WT 6 OZ (170g)











When Using This Product (When using this product)
  • Keep away from face to avoid breathing it

  • Keep out of eyes.  Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

is rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.

  • May stain some fabrics


Advanced Ingredient Data


Raw Label Data

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