SPL v5
SPL
SPL Set ID 33ad783f-b62f-6a70-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.7 g) Zinc Oxide (7 g)
Inactive Ingredients
Lecithin, Soybean Polyglyceryl-3 Ricinoleate Sodium Benzoate Tricaprin Lauryl Glucoside Octyldodecanol Glyceryl Stearate Citrate Docosanol Potassium Sorbate Decyl Oleate Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-4 Caprate Jojoba Oil Aluminum Oxide Arachidyl Alcohol Sorbic Acid Citric Acid Monohydrate Phenoxyethanol Water Glycerin Xanthan Gum Cetyl Alcohol Sorbitan Monostearate Stearyl Alcohol Sunflower Oil Trihydroxystearin Magnesium Aluminum Silicate Isostearic Acid Alcohol Phytate Sodium Silicon Dioxide Yellow Wax Polyglyceryl-2 Dipolyhydroxystearate Ferric Oxide Red Isoamyl Laurate Stearic Acid Morinda Citrifolia Fruit Mica Isoamyl Cocoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-01 Until 2016-12-01

Description

Titanium Dioxide 4.7% Zinc Oxide 7.0%


Medication Information

Description

Titanium Dioxide 4.7% Zinc Oxide 7.0%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun
Section 51727-6

Inactive Ingredients: water, glycerin, decyl oleate, isoamyl cocoate, isoamyl laurate, octyldodecanol, polyglyceryl-4 caprate, caprylic/capric triglyceride, cetyl alcohol, helianthus annuus (sunflower) seed oil, polyglyceryl-2 dipolyhydroxystearate, glyceryl stearate citrate, stearic acid, morinda citrifilia fruit extract, beeswax, jojoba esters, mica, iron oxides, silica, sorbitan stearate, stearyl alcohol, behenyl alcohol, sodium carboxymethyl C10-16 alkyl glucoside, lauryl glucoside, magnesium aluminum silicate, xanthan gum, citric acid, isostearic acid, lecithin, polyglyceryl-3polyricinoleate, polyhydroxysteric acid, sodium phytate, trihydroxystearin, alumina, arachidyl alcohol, sorbic acid, alcohol denat., potassium sorbate, sodium benzoate, fragrance*, phenoxyehtanol

*natural fragrance

Section 51945-4

Burt's Bees

BB Cream

with Noni Extract

LIGHT/MED

Broad Spectrum SPF 15

Net Wt 1.7 oz / 48.1g

Section 55105-1

Sunscreen

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Directions
  • Use in the morning after cleansing
  • Apply liberally 15 minutes before sun exposure
  • Children under 6 months: Ask a doctor
  • Use a water resistent sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 ethe sun, especially from 10 a.m.- 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • reapply at least every 2 hours
  • use a water resistent sunscreen if swimming or sweating
Questions?

(800) 849-7112 or www.burtsbees.com

Active Ingredients

Titanium Dioxide 4.7%

Zinc Oxide 7.0%

Other Information:

  • Protect this product from heat and direct sun.
Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.


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 aging caused by the sun
Section 51727-6 (51727-6)

Inactive Ingredients: water, glycerin, decyl oleate, isoamyl cocoate, isoamyl laurate, octyldodecanol, polyglyceryl-4 caprate, caprylic/capric triglyceride, cetyl alcohol, helianthus annuus (sunflower) seed oil, polyglyceryl-2 dipolyhydroxystearate, glyceryl stearate citrate, stearic acid, morinda citrifilia fruit extract, beeswax, jojoba esters, mica, iron oxides, silica, sorbitan stearate, stearyl alcohol, behenyl alcohol, sodium carboxymethyl C10-16 alkyl glucoside, lauryl glucoside, magnesium aluminum silicate, xanthan gum, citric acid, isostearic acid, lecithin, polyglyceryl-3polyricinoleate, polyhydroxysteric acid, sodium phytate, trihydroxystearin, alumina, arachidyl alcohol, sorbic acid, alcohol denat., potassium sorbate, sodium benzoate, fragrance*, phenoxyehtanol

*natural fragrance

Section 51945-4 (51945-4)

Burt's Bees

BB Cream

with Noni Extract

LIGHT/MED

Broad Spectrum SPF 15

Net Wt 1.7 oz / 48.1g

Section 55105-1 (55105-1)

Sunscreen

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Directions
  • Use in the morning after cleansing
  • Apply liberally 15 minutes before sun exposure
  • Children under 6 months: Ask a doctor
  • Use a water resistent sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 ethe sun, especially from 10 a.m.- 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • reapply at least every 2 hours
  • use a water resistent sunscreen if swimming or sweating
Questions?

(800) 849-7112 or www.burtsbees.com

Active Ingredients

Titanium Dioxide 4.7%

Zinc Oxide 7.0%

Other Information:

  • Protect this product from heat and direct sun.
Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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