Tinted Bb Moisturizing Creme Broad-spectrum Spf 20 Sunscreen

Tinted Bb Moisturizing Creme Broad-spectrum Spf 20 Sunscreen
SPL v2
SPL
SPL Set ID 3039afd2-01a2-5c68-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.473 g) Avobenzone (1.389 g)
Inactive Ingredients
Gluconolactone Phenoxyethanol Mica Apple Fruit Oil Laminaria Digitata Dimethicone Glyceryl Caprylate Sodium Chloride Hydrolyzed Jojoba Esters (acid Form) Calcium Gluconate Potassium Sorbate Titanium Dioxide Lentil Propylene Carbonate Tetrahexyldecyl Ascorbate Alpha-tocopherol Acetate Sodium Lactate Water Isododecane 1,1'-((1-methyl-1,2-ethanediyl)2-propenoic Acid, Bis(oxy(1-methyl-2,1-ethanediyl))) Ester Isoamyl Laurate Ethylhexyl Palmitate Magnesium Sulfate Microcrystalline Wax Phenyl Trimethicone Hydrogenated Castor Oil Stannic Oxide Citrullus Lanatus Var. Lanatus Whole Glyceryl Monoundecylenate Glycerin Octyldodecyl Oleate Isolan Cyclomethicone Isoamyl Cocoate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-09-01

Description

Avobenzone 3.0% Octinoxate 7.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0% Octinoxate 7.5%

Uses
  • helps prevent sunburn
  • is 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

Directions

  • apply smoothly on cleased skin
  • apply liberally 15 minutes before sun exposure
  • use a water-resistant sunscreen if swimming or sweating
  • reapply 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 10a.m.-2p.m
  • wear long-sleeve shirts, pants, hats, and sunglasses
Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes. Rinse with water to remove.

Other Information
  • may stain some fabrics
  • protect this product from excessive heat and direct sun
  • do not store at temperatures below 32oF (0oC) or above 120oF (49oC)
Active Ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Inactive Ingredients

aqua (water/eau), isododecane, glycerin, acrylates crosspolymer, isoamyl laurate, octyldodecyl oleate, polyglyceryl-4 diisostearate/polyhydroxustearate/sebacate, titanium dioxide (CI 77891), polypropylene, cyclopentasiloxane, ethylhexyl palmitate, dimethicone, magnesium sulfate, glyceryl caprylate, microcrystalline wax, phenyl trimethicone, quaternium-90 bentonite, sodium chloride, hydrogenated castor oil, hydrolyzed jojoba esters, gluconolactone, mica (CI 77019), citrullur lanatus (watermelon), polysilicone-11, isoamyl cocoate, iron oxides (CI 77491, CI 77492, CI 77499), sodium benzoate, lens esculenta (lentil) fruit extract, propylene carbonate, glyceryl undecylenate, pyrus malus (apple) fruit extract, tetrahexyldecyl ascorbate, tocopheryl acetate, laminaria digitata extract, sodium lactate, hydroxypropyl cyclodextrin, sodium PCA, calcium gluconate, phenoxyethanol, potassium sorbate, tin oxide, palmitoyl tripeptide-38

Principal Display Panel

Keep Out of the Reach of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • helps prevent sunburn
  • is 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

Directions

  • apply smoothly on cleased skin
  • apply liberally 15 minutes before sun exposure
  • use a water-resistant sunscreen if swimming or sweating
  • reapply 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 10a.m.-2p.m
  • wear long-sleeve shirts, pants, hats, and sunglasses
Do Not Use (Do not use)

Do not use on damaged or broken skin.

When Using (When using)

When using this product keep out of eyes. Rinse with water to remove.

Other Information
  • may stain some fabrics
  • protect this product from excessive heat and direct sun
  • do not store at temperatures below 32oF (0oC) or above 120oF (49oC)
Active Ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Inactive Ingredients (Inactive ingredients)

aqua (water/eau), isododecane, glycerin, acrylates crosspolymer, isoamyl laurate, octyldodecyl oleate, polyglyceryl-4 diisostearate/polyhydroxustearate/sebacate, titanium dioxide (CI 77891), polypropylene, cyclopentasiloxane, ethylhexyl palmitate, dimethicone, magnesium sulfate, glyceryl caprylate, microcrystalline wax, phenyl trimethicone, quaternium-90 bentonite, sodium chloride, hydrogenated castor oil, hydrolyzed jojoba esters, gluconolactone, mica (CI 77019), citrullur lanatus (watermelon), polysilicone-11, isoamyl cocoate, iron oxides (CI 77491, CI 77492, CI 77499), sodium benzoate, lens esculenta (lentil) fruit extract, propylene carbonate, glyceryl undecylenate, pyrus malus (apple) fruit extract, tetrahexyldecyl ascorbate, tocopheryl acetate, laminaria digitata extract, sodium lactate, hydroxypropyl cyclodextrin, sodium PCA, calcium gluconate, phenoxyethanol, potassium sorbate, tin oxide, palmitoyl tripeptide-38

Principal Display Panel

Keep Out of the Reach of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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