Sun Bum Premium Spf 15 Sunscreen Tanning Oil

Sun Bum Premium Spf 15 Sunscreen Tanning Oil
SPL v2
SPL
SPL Set ID 96fd64db-a1fa-4751-9b8a-091efc0c9614
Route
TOPICAL
Published
Effective Date 2019-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Mineral Oil Aloe Vera Leaf Apricot Kernel Oil Jojoba Oil Almond Oil Sunflower Oil Coconut Oil Linseed Oil Avocado Oil Argan Oil Macadamia Oil Olive Oil Passiflora Edulis Seed Oil Rosa Canina Fruit Oil Camellia Oil Cocoa Butter Green Tea Leaf Sclerocarya Birrea Seed Oil

Identifiers & Packaging

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

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5% 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

• 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

Do Not Use

on damaged or broken skin

Drug Facts

Questions?

Call 1-877-978-6286

Other Information

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%,

Octisalate 5% Octocrylene 10%

Inactive Ingredients

mineral oil, aloe barbadensis leaf extract, prunus armeniaca (apricot) kernel oil, simmondsia chinensis (jojoba) seed oil, prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed oil, cocos nucifera (coconut) oil, linum usitatissimum (linseed) seed oil, persea gratissima (avocado) oil, argania spinosa kernel oil, macadamia ternifolia seed oil, olea europaea (olive) fruit oil, passiflora edulis seed oil, rosa canina fruit oil, camellia oleifera seed oil, theobroma cacao (cocoa) seed butter, camellia sinensis leaf powder, sclerocarya birrea seed oil, hydrogenated vegetable oil, fragrance

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

Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Questions?

Call 1-877-978-6286

Other Information

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%,

Octisalate 5% Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

mineral oil, aloe barbadensis leaf extract, prunus armeniaca (apricot) kernel oil, simmondsia chinensis (jojoba) seed oil, prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed oil, cocos nucifera (coconut) oil, linum usitatissimum (linseed) seed oil, persea gratissima (avocado) oil, argania spinosa kernel oil, macadamia ternifolia seed oil, olea europaea (olive) fruit oil, passiflora edulis seed oil, rosa canina fruit oil, camellia oleifera seed oil, theobroma cacao (cocoa) seed butter, camellia sinensis leaf powder, sclerocarya birrea seed oil, hydrogenated vegetable oil, fragrance

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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