Label: SUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS- avobenzone, homosalte, octisalate, octocrylene cream
- NDC Code(s): 66097-003-51
- Packager: C.F.E.B. Sisley
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 30, 2023
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: ask a doctor.
- 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: Sun Protection Measures:
- Limit time in the sun especially from 10 am to 2 pm.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
- Other information
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Inactive ingredients
water, glycerin, butyrospermum parkii (shea butter), glyceryl stearate, peg-100 stearate, butylene glycol, potassium cetyl phosphate, silica, stearyl alcohol, tocopherol acetate, allantoin, physalis alkekengi calyx extract, cucumis sativus (cucumber) fruit extract, rhodochrosite extract, sodium acryloyldimethyltaurate/vp crosspolymer, xanthan gum, pentylene glycol, disodium edta, sodium hydroxide, citric acid, thymus mastichina flower oil, salvia officinalis (sage) oil, phenoxyethanol, phenoxyethanol, sorbic acid, potassium sorbate, linalool, limonene
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INGREDIENTS AND APPEARANCE
SUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS
avobenzone, homosalte, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66097-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SHEANUT OIL (UNII: O88E196QRF) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALLANTOIN (UNII: 344S277G0Z) PHYSALIS ALKEKENGI CALYX (UNII: AL7F9NO9HR) CUCUMBER (UNII: YY7C30VXJT) MANGANESE CARBONATE (UNII: 9ZV57512ZM) SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G) XANTHAN GUM (UNII: TTV12P4NEE) PENTYLENE GLYCOL (UNII: 50C1307PZG) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457) SAGE OIL (UNII: U27K0H1H2O) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66097-003-51 1 in 1 BOX 01/21/2013 1 51.5 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/21/2013 Labeler - C.F.E.B. Sisley (262279246)
