Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f7a3f518-20ef-4c5f-89a1-0ee7200386bb
Route
TOPICAL
Published
Effective Date 2016-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene (6 g)
Inactive Ingredients
Isobutane Water Isohexadecane 2-ethylhexyl Benzoate Dibutyl Adipate Ethylhexyl Methoxycrylene Sodium Chloride Polyethylene Glycol 400 Caprylyl Glycol Glycerin Sodium Citrate, Unspecified Form Peg-8 Dimethicone Aloe Vera Leaf Octyldodecanol Vitamin A Palmitate Silicon Dioxide .alpha.-tocopherol Acetate Ascorbic Acid Sodium Propoxyhydroxypropyl Thiosulfate Silica Phenoxyethanol Methylparaben Butylparaben Ethylparaben Isobutylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-11

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

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 temperature above 1200F. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

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 production measures including:
  • limit time in the sun, especially from 10 a.m. to 2 p.m.
  • wear long-sleeved 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 excessing heat and direct sun

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Inactive Ingredients

Isobutane, Water, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Dibutyl Adipate, Lauryl PEG-8 Dimethicone, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Caprylyl Glycol, Glycerin, Sodium Citrate, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben.

Questions Or Comments?

Call 1-800-697-9868  Mon-Fri

Principal Display Panel

NDC:  41250-928-55

meijer

tear free

Kids Sunscreen

continuous spray

pediatrician tested

UVA/UVB protection

50+

Broad Spectrum

SPF 50+

Water Resistant

(80 minutes)

NET WT 6 OZ.  (170 g)

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

if rash occurs

Keep Out of Reach of Children.
  • If product is swallowed, get medical help or contact a Poison Control center right away.
  • Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

  • 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 temperature above 1200F. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

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 production measures including:
  • limit time in the sun, especially from 10 a.m. to 2 p.m.
  • wear long-sleeved 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 excessing heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Inactive Ingredients (Inactive ingredients)

Isobutane, Water, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Dibutyl Adipate, Lauryl PEG-8 Dimethicone, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Caprylyl Glycol, Glycerin, Sodium Citrate, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben.

Questions Or Comments? (Questions or comments?)

Call 1-800-697-9868  Mon-Fri

Principal Display Panel

NDC:  41250-928-55

meijer

tear free

Kids Sunscreen

continuous spray

pediatrician tested

UVA/UVB protection

50+

Broad Spectrum

SPF 50+

Water Resistant

(80 minutes)

NET WT 6 OZ.  (170 g)

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)

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

  • May stain some fabrics.


Advanced Ingredient Data


Raw Label Data

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