Sunbum spf 50 cream

Active ingredients purpose

Octisalate - 5.00% Sunscreen
Octinoxate - 7.50%
Oxybenzone - 6.00%
Zinc Oxide - 7.00%

Otc - purpose section

Indications & usage section

Uses

- helps prevent sunburn
- if used as directed with other sun protection messures ( see Directions) decreases the risk of skin cancer and early skin aging caused by sun.

Warnings

For external use only
Do not useon damaged or broken skin
When using this productkeep out of eyes. Rinse with water to remove.
Stop use and ask a doctor ifrash occurs
Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Otc - keep out of reach of children section

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
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-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive ingredients

Aloe Barbadensis Leaf Extract
Beeswax
Cetyl Dimethicone
Cetyl PEG/PPG-10/1 Dimethicone
Cyclohexasiloxane
Cyclopentasiloxane
Diisopropyl Adipate
DMDM Hydantoin
Ethylhexyl Palmitate
Ethylhexyl Stearate
Fragrance
Glycerin
Hydrated Silica
Hydrogenated Castor Oil
Polyethylene
Sodium Chloride
Theobroma Cacao (Cocoa) Seed Butter
Tocopheryl Acetate
Triethoxycaprylylsilane
Water

Ingredients and appearance - Product information

Sunbum spf 50 cream- Octisalate - 5.00% octinoxate - 7.50% oxybenzone - 6.00% zinc oxide - 7.00%

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 69039-559
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Octisalate ( UNII: 4X49Y0596W)( Octisalate - UNII: 4X49Y0596W ) 5 gin 100 mL
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 7.5 gin 100 mL
Oxybenzone ( UNII: 95OOS7VE0Y)( Oxybenzone - UNII: 95OOS7VE0Y ) 6 gin 100 mL
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc cation - UNII: 13S1S8SF37 ) 7in 100 mL

Inactive Ingredients

Ingredient Name Code
Aloe ( UNII: V5VD430YW9)
Yellow wax ( UNII: 2ZA36H0S2V)
Cetyl dimethicone 45 ( UNII: IK315POC44)
Cetyl peg/ppg-10/1 dimethicone (hlb 3) ( UNII: G300307ZXP)
Cyclomethicone 6 ( UNII: XHK3U310BA)
Cyclomethicone 5 ( UNII: 0THT5PCI0R)
Diisopropyl adipate ( UNII: P7E6YFV72X)
Dmdm hydantoin ( UNII: BYR0546TOW)
Ethylhexyl palmitate ( UNII: 2865993309)
Ethylhexyl stearate ( UNII: EG3PA2K3K5)
Glycerin ( UNII: PDC6A3C0OX)
Hydrated silica ( UNII: Y6O7T4G8P9)
Hydrogenated castor oil ( UNII: ZF94AP8MEY)
Polyethylene glycol 200 ( UNII: R95B8J264J)
Sodium chloride ( UNII: 451W47IQ8X)
Cocoa butter ( UNII: 512OYT1CRR)
.alpha.-tocopherol acetate ( UNII: 9E8X80D2L0)
Triethoxycaprylylsilane ( UNII: LDC331P08E)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part352 USA

Labeler - Sun Bum( 019516317)

Establishment

Name ID/FEI Business Operations
Sun Bum 019516317 manufacture( 69039-559), label( 69039-559)

Package label.principal display panel