Sun Bum Premium Sunscreen Browning Lotion Spf 15

Sun Bum Premium Sunscreen Browning Lotion Spf 15
SPL v2
SPL
SPL Set ID 22b6555a-30a6-4d4d-9a8c-5a23fda864d7
Route
TOPICAL
Published
Effective Date 2021-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Homosalate (50 mg) Octisalate (100 mg) Octocrylene
Inactive Ingredients
Fd&c Red No. 4 D&c Red No. 33 Fd&c Yellow No. 6 Papaya Juice Glyceryl Monostearate Water Medium-chain Triglycerides Coconut Oil Peg-100 Stearate Caramel Cetyl Alcohol Aloe Vera Leaf Argan Oil Kukui Nut Arabica Coffee Oil Ginger Helianthus Annuus Flowering Top Macadamia Oil Glycerin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) .alpha.-tocopherol Acetate Tocopherol Magnesium Sulfate, Unspecified Form Manganese Sulfate Isohexadecane Polysorbate 60 Caffeine Phenoxyethanol Ethylhexylglycerin Sodium Hydroxide Fd&c Blue No. 1 Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Sodium Alginate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-01-01

Description

Avobenzone 2%, Homosalte 5%, Octisalate 2%, Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2%, Homosalte 5%, Octisalate 2%, Octocrylene 10%

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

• shake well before use • 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

Drug Facts

Questions?

1-877-978-6286

Other Information

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 2%, Homosalte 5%,

Octisalate 2%, Octocrylene 10%

Inactive Ingredients

water, caprylic/capric triglyceride, cocos nucifera (coconut) oil, glyceryl stearate, PEG-100 stearate, fragrance, caramel, cetyl alcohol, aloe barbadensis leaf juice, argania spinosa (argan) kernel oil, aleurites moluccana (kukui) seed oil, coffea arabica (coffee) seed oil, caprica papaya fruit extract, zingiber officinale (ginger) root extract, helianthus annuus (sunflower) extract, macadamia ternifolia seed oil, glycerin, hydrolyzed algin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylate/c 10-30 alkyl acrylate crosspolymer, tocopheryl acetate, tocopherol, magnesium sulfate, manganese sulfate, isohexadecane, polysorbate 60, caffeine, phenoxyethanol, ethylhexylglycerin, sodium hydroxide, blue no.1, red no.33, red no.4, yellow no.6

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

• shake well before use • 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

Drug Facts

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 2%, Homosalte 5%,

Octisalate 2%, Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

water, caprylic/capric triglyceride, cocos nucifera (coconut) oil, glyceryl stearate, PEG-100 stearate, fragrance, caramel, cetyl alcohol, aloe barbadensis leaf juice, argania spinosa (argan) kernel oil, aleurites moluccana (kukui) seed oil, coffea arabica (coffee) seed oil, caprica papaya fruit extract, zingiber officinale (ginger) root extract, helianthus annuus (sunflower) extract, macadamia ternifolia seed oil, glycerin, hydrolyzed algin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylate/c 10-30 alkyl acrylate crosspolymer, tocopheryl acetate, tocopherol, magnesium sulfate, manganese sulfate, isohexadecane, polysorbate 60, caffeine, phenoxyethanol, ethylhexylglycerin, sodium hydroxide, blue no.1, red no.33, red no.4, yellow no.6

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask a Doctor If (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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