FACE CREAM 50- homosalate, octisalate, octocrylene, zinc oxide cream 
Sun Bum LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Face Cream 50

Drug Facts

Active Ingredients

Homosalate 10%, Octisalate 5%

Octocrylene 10%, Zinc oxide 7%

Purpose

Sunscreen 

Uses

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

Keep out of reach of children.

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

Directions

• shake well before use

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating

• immediately after towel drying • 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 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

water, C12-15 alkyl benzoate, ethylhexyl palmitate, ethylhexyl stearate, cetyl peg/ppg-10/1 dimethicone, glycerin, hydrogenated castor oil, isoamyl cocoate, hydrogenated ethylhexyl olivate, hydrated silica, polyethylene, tocopheryl acetate, theobroma cacao seed butter, aloe barbadensis leaf juice, beeswax, hydrogenated olive oil unsaponifiables, fragrance, sodium chloride, triethoxycaprylysilane, phenoxyethanol, ethylhexylglycerin

Other Information

• protect this product from excessive heat and direct sun
• keep outer card for complete directions and warnings

Questions?

1-877-978-6286

Package Labeling:

Outer LabelInner Label

FACE CREAM 50 
homosalate, octisalate, octocrylene, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-661
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
ISOAMYL COCOATE (UNII: 14OG46E98E)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-661-0030 mL in 1 JAR; Type 0: Not a Combination Product01/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/06/2023
Labeler - Sun Bum LLC (028642574)

Revised: 1/2023
Document Id: f29b7f9f-86cc-72f5-e053-2995a90ab4f6
Set id: de7eaa27-f8e3-4238-a3a3-2b31d65916e6
Version: 1
Effective Time: 20230119
 
Sun Bum LLC