Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Pineapple

Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Pineapple
SPL v2
SPL
SPL Set ID 3eb190c7-4342-44ee-82a7-769f9ce5f15b
Route
TOPICAL
Published
Effective Date 2020-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octocrylene (80 mg) Octisalate (50 mg)
Inactive Ingredients
Aloe Vera Leaf Argan Oil Levomenol Green Tea Leaf Medium-chain Triglycerides Calendula Officinalis Flower Cetyl Alcohol Lemon Peel Cucumber Diisobutyl Adipate Equisetum Arvense Branch Ethylhexyl Palmitate Ginkgo Hydrogenated Olive Oil Unsaponifiables Isostearyl Linoleate Macrocystis Pyrifera Mineral Oil Ceresin Asian Ginseng Polyethylene Glycol 400 Polysorbate 80 Propylene Glycol Punica Granatum Root Bark Rosemary Saccharin Salix Alba Bark Sage Silicon Dioxide Cocoa Butter .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-01-01

Description

Avobenzone 3%, Homosalate 10% Octocrylene 8%, Octisalate 5%,

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10% Octocrylene 8%, Octisalate 5%,

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

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
  • children under 6 months of age: ask a doctor

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 value 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-sleeved shirts, pants, hats and sunglasses
Do Not Use

on damaged or broken skin.

Questions?

1 (877) 978-6286

Other Information

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%

Octocrylene 8%, Octisalate 5%,

Inactive Ingredients

aloe barbadensis leaf extract, argania spinosa kernel oil, bisabolol, camellia sinensis leaf extract, caprylic/capric triglyceride, calendula officinalis flower extract, cetyl alcohol, citrus grandis fruit extract, citrus limon peel extract, cucumis sativus (cucumber) fruit extract, diisobutyl adipate, equisetum arvense extract, ethylhexyl palmitate, fragrance, ginkgo biloba leaf extract, hydrogenated ethylhexyl olivate, hydrogenated olive oil unsaponifiables, isostearyl linoleate, macrocystis pyrifera extract, mineral oil, ozokerite, panax ginseng root extract, PEG-8, polysorbate 80, propylene glycol, punica granatum extract, rosmarinus officinalis extract, saccharin, salix alba (willow) bark extract, salvia officinalis (sage) extract, silica, theobroma cacao seed butter, tocopheryl acetate, tocopheryl linoleate/oleate, water

When Using This Product

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 swallowed, get medical help or contact a Poison Control Center immediately.


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

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
  • children under 6 months of age: ask a doctor

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 value 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-sleeved shirts, pants, hats and sunglasses
Do Not Use (Do not use)

on damaged or broken skin.

Questions?

1 (877) 978-6286

Other Information (Other information)

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 10%

Octocrylene 8%, Octisalate 5%,

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf extract, argania spinosa kernel oil, bisabolol, camellia sinensis leaf extract, caprylic/capric triglyceride, calendula officinalis flower extract, cetyl alcohol, citrus grandis fruit extract, citrus limon peel extract, cucumis sativus (cucumber) fruit extract, diisobutyl adipate, equisetum arvense extract, ethylhexyl palmitate, fragrance, ginkgo biloba leaf extract, hydrogenated ethylhexyl olivate, hydrogenated olive oil unsaponifiables, isostearyl linoleate, macrocystis pyrifera extract, mineral oil, ozokerite, panax ginseng root extract, PEG-8, polysorbate 80, propylene glycol, punica granatum extract, rosmarinus officinalis extract, saccharin, salix alba (willow) bark extract, salvia officinalis (sage) extract, silica, theobroma cacao seed butter, tocopheryl acetate, tocopheryl linoleate/oleate, water

When Using This Product (When using this product)

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 swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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