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

Purpose

Sunscreen

Description

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


Medication Information

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.

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

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

Other Information

protect this product from excessing heat and direct sun

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.

Description

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

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)

Do Not Use

on damaged or broken skin

Active Ingredients

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

Questions Or Comments?

Call 1-800-697-9868  Mon-Fri

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

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.

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

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

Other Information (Other information)

protect this product from excessing heat and direct sun

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.

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)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-800-697-9868  Mon-Fri

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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