FACE CREAM 50- homosalate, octisalate, octocrylene, zinc oxide cream

Face Cream 50 by

Drug Labeling and Warnings

Face Cream 50 by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Homosalate 10%, Octisalate 5%

Octocrylene 10%, Zinc oxide 7%

Purpose

Sunscreen 

Uses

• helps prevent sunburn
• if 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.

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:

INGREDIENTS AND APPEARANCE

FACE CREAM 50 
homosalate, octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-661
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-661-00	30 mL in 1 JAR; Type 0: Not a Combination Product	01/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/06/2023

Labeler - Sun Bum LLC (028642574)