Label: FACE CREAM 50- homosalate, octisalate, octocrylene, zinc oxide cream
- NDC Code(s): 69039-661-00
- Packager: Sun Bum LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 19, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
- Warnings
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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
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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
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INGREDIENTS AND APPEARANCE
FACE CREAM 50
homosalate, octisalate, octocrylene, zinc oxide creamProduct 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)
