bb cream

bb cream
SPL v1
SPL
SPL Set ID 7475ddf3-b575-489f-8226-fe26291153c1
Route
topical
Published
Effective Date 2015-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (25 mg) octisalate (50 mg) octocrylene (27 mg)
Inactive Ingredients
water diethylhexyl carbonate castor oil glycerin ethyl macadamiate cetyl peg/ppg-10/1 dimethicone (hlb 2) silicon dioxide hydrogenated castor oil isododecane microcrystalline wax neopentyl glycol diheptanoate abelmoschus moschatus seed squalane palmitoyl lysyldioxymethionyllysine .alpha.-tocopherol acetate magnesium sulfate hexyl laurate polyglyceryl-4 isostearate glyceryl dibehenate tribehenin sodium chloride hydroxypropyl .beta.-cyclodextrin sunflower oil phenylethyl resorcinol sodium benzoate potassium sorbate phenoxyethanol ethylhexylglycerin titanium dioxide ferric oxide yellow ferric oxide red ferrosoferric oxide

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
otc monograph final active Since 2013-03-15

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Purpose

Sunscreen

Directions
  • 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: Ask a doctor
Other Information
  • Protect this product from excessive heat and direct sun
Inactive Ingredients

Water, Diethylhexyl Carbonate, Ricinus Communis (Castor) Seed Oil, Glycerin,Ethyl Macadamiate, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Hydrogenated Castor Oil, Isododecane, Microcrystalline Wax, Neopentyl Glycol Diheptanoate, Hibiscus Abelmoschus Extract, Squalane, Palmitoyl Tripeptide-38, Tocopheryl Acetate, Magnesium Sulfate, Hexyl Laurate, Polyglyceryl-4 Isostearate, Glyceryl Dibehenate, Tribehenin, Sodium Chloride, Hydroxypropyl Cyclodextrin, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Behenate, Phenylethyl Resorcinol, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin. May Contain (+/-): Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) <21101>

Description

Drug Facts

Use
  • Helps prevent sunburn
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help right away.
Section 50566-9
  • Keep out of eyes. Stop use if irritation occurs.
Section 50570-1
  • Do not use on damaged or broken skin.
Active Ingredients

Avobenzone, 3.0%,

Homosalate, 2.5%,

Octisalate, 5.0%,

Octocrylene, 2.7%

Principal Display Panel 30 Ml Tube Carton Dark

BB CREAM

BROAD SPECTRUM

SPF 25

NET WT.

1 FL. OZ./30 ML e

Principal Display Panel 30 Ml Tube Carton Fair

BB CREAM

BROAD SPECTRUM

SPF 25

NET WT.

1 FL. OZ./30 ML e

Principal Display Panel 30 Ml Tube Carton Light

BB CREAM

BROAD SPECTRUM

SPF 25

NET WT.

1 FL. OZ./30 ML e

Principal Display Panel 30 Ml Tube Carton Medium

BB CREAM

BROAD SPECTRUM

SPF 25

NET WT.

1 FL. OZ./30 ML e


Structured Label Content

Purpose

Sunscreen

Directions
  • 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: Ask a doctor
Other Information
  • Protect this product from excessive heat and direct sun
Inactive Ingredients

Water, Diethylhexyl Carbonate, Ricinus Communis (Castor) Seed Oil, Glycerin,Ethyl Macadamiate, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Hydrogenated Castor Oil, Isododecane, Microcrystalline Wax, Neopentyl Glycol Diheptanoate, Hibiscus Abelmoschus Extract, Squalane, Palmitoyl Tripeptide-38, Tocopheryl Acetate, Magnesium Sulfate, Hexyl Laurate, Polyglyceryl-4 Isostearate, Glyceryl Dibehenate, Tribehenin, Sodium Chloride, Hydroxypropyl Cyclodextrin, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Behenate, Phenylethyl Resorcinol, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin. May Contain (+/-): Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) <21101>

Use
  • Helps prevent sunburn
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help right away.
Section 50566-9 (50566-9)
  • Keep out of eyes. Stop use if irritation occurs.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin.
Active Ingredients

Avobenzone, 3.0%,

Homosalate, 2.5%,

Octisalate, 5.0%,

Octocrylene, 2.7%

Principal Display Panel 30 Ml Tube Carton Dark (PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - DARK)

BB CREAM

BROAD SPECTRUM

SPF 25

NET WT.

1 FL. OZ./30 ML e

Principal Display Panel 30 Ml Tube Carton Fair (PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - FAIR)

BB CREAM

BROAD SPECTRUM

SPF 25

NET WT.

1 FL. OZ./30 ML e

Principal Display Panel 30 Ml Tube Carton Light (PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - LIGHT)

BB CREAM

BROAD SPECTRUM

SPF 25

NET WT.

1 FL. OZ./30 ML e

Principal Display Panel 30 Ml Tube Carton Medium (PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - MEDIUM)

BB CREAM

BROAD SPECTRUM

SPF 25

NET WT.

1 FL. OZ./30 ML e


Advanced Ingredient Data


Raw Label Data

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