Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Coconut

Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 Coconut
SPL v2
SPL
SPL Set ID f4fd21db-846f-44e9-a134-235fe198289a
Route
TOPICAL
Published
Effective Date 2019-05-23
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 Cetyl Alcohol Diisobutyl Adipate Equisetum Arvense Branch Ethylhexyl Palmitate Hydrogenated Olive Oil Unsaponifiables Isostearyl Linoleate Mineral Oil Ceresin Polysorbate 80 Propylene Glycol Punica Granatum Root Bark Rosemary Saccharin Salix Alba Bark Sage Silicon Dioxide .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-01-01

Description

Avobenzone 3%, Homosalate 10% Octocrylene 8%, Octyl Salicylate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10% Octocrylene 8%, Octyl Salicylate 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 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
Questions?

call 1 (877) 978-6286

Do Not Use 

on damaged or broken skin.

Other Information

protect this product from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%

Octocrylene 8%, Octyl Salicylate 5%

Inactive Ingredients

aloe barbadensis leaf extract, argania spinosa kernel oil, bisabolol, camellia sinensis leaf extract, caprylic/capric triglyceride, cetyl alcohol, cucumis sativus (cucumber) fruit extract, diisobutyl adipate, equisetum arvense extract, ethyl hexyl palmitate, fragrance, hydrogenated ethylhexyl olivate, hydrogenated olive oil unsaponifiables, isostearyl linoleate, mineral oil, ozokerite, 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 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
Questions?

call 1 (877) 978-6286

Do Not Use  (Do not use )

on damaged or broken skin.

Other Information

protect this product from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%

Octocrylene 8%, Octyl Salicylate 5%

Inactive Ingredients

aloe barbadensis leaf extract, argania spinosa kernel oil, bisabolol, camellia sinensis leaf extract, caprylic/capric triglyceride, cetyl alcohol, cucumis sativus (cucumber) fruit extract, diisobutyl adipate, equisetum arvense extract, ethyl hexyl palmitate, fragrance, hydrogenated ethylhexyl olivate, hydrogenated olive oil unsaponifiables, isostearyl linoleate, mineral oil, ozokerite, 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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