Youth Activating Bb Cream Spf30 Shade 3

Youth Activating Bb Cream Spf30 Shade 3
SPL v8
SPL
SPL Set ID c84207c4-a779-4c00-a486-86eaf8ece169
Route
TOPICAL
Published
Effective Date 2017-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (63 mg) Titanium Dioxide (23.6 mg)
Inactive Ingredients
Water Argan Oil .alpha.-tocopherol Medium-chain Triglycerides Silicon Dioxide Babassu Oil Muscadine Grape Phenyl Trimethicone Propanediol Dimethicone Butyloctyl Salicylate Glycerin Trisiloxane Magnesium Sulfate, Unspecified Form Pantothenic Acid Grape Ascorbic Acid Levomenol Caesalpinia Spinosa Resin Phenoxyethanol Butylene Glycol Polyglyceryl-2 Stearate Isostearic Acid Sucrose Dilaurate Disteardimonium Hectorite Triethoxycaprylylsilane Aluminum Oxide Sodium Cocoyl Glutamate Stearic Acid Ethylhexylglycerin Trisodium Ethylenediamine Disuccinate Superoxide Dismutase (saccharomyces Cerevisiae) 1,2-hexanediol Caprylyl Glycol Pea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-22

Description

Zinc Oxide 6.30% Titanium Dioxide 2.36%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 6.30% Titanium Dioxide 2.36%

Uses
  • Helps prevent sunburn
Warnings
  • For external use only
Directions
  • Apply generously 15 minutes before sun exposure
  • Children under 6 months of age ask a doctor
  • Sun Protection Measures. Spending time in the sun increases the risk of skin cancer and early skin aging caused bu the sun. To decrease the 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
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if Simming or sweating
Do Not Use 
  • on damaged or broken skin
Other Information
  • Protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients

Zinc Oxide 6.30%

Titanium Dioxide 2.36%

Inactive Ingredients

Water, Argania Spinosa (Argan) Kernel Oil, Tocopheryl Acetate (Vitamin E), Caprylic/Capric Triglyceride (Fractionated Coconut Oil), Silica, Orbignya Oleifera (Moringa Tree ) Seed Oil, Vitis Rotundifolia (Muscadine Grape) Fruit Extract, Enteromorpha Compressa (Green Algae) Extract, Phenyl Trimethicone, Propanediol, Dimethicone, Butyloctyl Salicylate, Glycerin, Polyhydroxystearic Acid, Polyglyceryl-4  Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-2 Oleate, Trisiloxane, Magnesium Sulfate, Alteromonas Ferment Extract, Panthenol (vitamin B5), Vitis Vinifera (Grape) Seed Extract, Magnesium Ascorbyl Phosphate (Vitamin C), Bisabolol, Caesalpinia Spinosa (Tara Tree) Gum, Phenoxyethanol, Butylene Glycol, Polyglyceryl-2 Stearate, Isostearic Acid, Sucrose Dilaurate, Lecithin, Polyglyceryl-3 Polyricinoleate,  Disteardimonium Hectorite, Triethoxycaprylylsilane, Cetearyl Dimethicone Crosspolymer, Alumina, Sodium Cocoyl Glutamate, Stearic Acid, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Dimethicone/Vinyl Dimethicone Crosspolymer, Superoxide Dismutase, 1,2-Hexanediol, Beta-Glucan, Caprylyl Glycol, Pisum Sativum (Pea) Extract May Contain Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), 77492, 77499)

Stop Use and Ask A Doctor

if rash occurs

When Using This Product 
  • keep out of eyes. Rinse with water to remove.
Keep Out of Reach of Children.

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


Structured Label Content

Uses (USES)
  • Helps prevent sunburn
Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)
  • For external use only
Directions (DIRECTIONS)
  • Apply generously 15 minutes before sun exposure
  • Children under 6 months of age ask a doctor
  • Sun Protection Measures. Spending time in the sun increases the risk of skin cancer and early skin aging caused bu the sun. To decrease the 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
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if Simming or sweating
Do Not Use  (Do not use )
  • on damaged or broken skin
Other Information (OTHER INFORMATION)
  • Protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients (ACTIVE INGREDIENTS)

Zinc Oxide 6.30%

Titanium Dioxide 2.36%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Argania Spinosa (Argan) Kernel Oil, Tocopheryl Acetate (Vitamin E), Caprylic/Capric Triglyceride (Fractionated Coconut Oil), Silica, Orbignya Oleifera (Moringa Tree ) Seed Oil, Vitis Rotundifolia (Muscadine Grape) Fruit Extract, Enteromorpha Compressa (Green Algae) Extract, Phenyl Trimethicone, Propanediol, Dimethicone, Butyloctyl Salicylate, Glycerin, Polyhydroxystearic Acid, Polyglyceryl-4  Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-2 Oleate, Trisiloxane, Magnesium Sulfate, Alteromonas Ferment Extract, Panthenol (vitamin B5), Vitis Vinifera (Grape) Seed Extract, Magnesium Ascorbyl Phosphate (Vitamin C), Bisabolol, Caesalpinia Spinosa (Tara Tree) Gum, Phenoxyethanol, Butylene Glycol, Polyglyceryl-2 Stearate, Isostearic Acid, Sucrose Dilaurate, Lecithin, Polyglyceryl-3 Polyricinoleate,  Disteardimonium Hectorite, Triethoxycaprylylsilane, Cetearyl Dimethicone Crosspolymer, Alumina, Sodium Cocoyl Glutamate, Stearic Acid, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Dimethicone/Vinyl Dimethicone Crosspolymer, Superoxide Dismutase, 1,2-Hexanediol, Beta-Glucan, Caprylyl Glycol, Pisum Sativum (Pea) Extract May Contain Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), 77492, 77499)

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

When Using This Product  (When using this product )
  • keep out of eyes. Rinse with water to remove.
Keep Out of Reach of Children. (Keep out of 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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