Label: DAYSTAR SHADE SPF MOISTURIZING SUNSCREEN- homosalate, zinc oxide, octisalate lotion
- NDC Code(s): 54997-056-00
- Packager: 4Life Research USA, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 7, 2024
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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DIRECTIONS:
- Apply generously and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours during sun exposure.
- Use a water-resistant sunscreen if swimming or sweating.
- 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 10:00 am-2:00 pm.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months of age: Ask a doctor.
- Other Information
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INACTIVE INGREDIENTS:
Water, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Glyceryl Stearate, Glycerin, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Isododecane, PEG-100 Stearate, Caprylic/Capric Triglyceride, Dimethicone, C12-20 Alkyl Glucoside, C14-22 Alcohol, Phenyl Trimethicone, Cetearyl Glucoside, Hydroxyapatite, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Benzyl Alcohol, Biosaccharide Gum-4, Caprylyl Glycol, Fragrance, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Ammonium Acryloyldimonium Hectorite, Cetearyl Alcohol, Xanthan Gum, Benzoic Acid, Lecithin, Linoleic Acid, Propylene Carbonate, Disodium EDTA, Tocopheryl Acetate, Oleic Acid, Tetrahexyldecyl Ascorbate, Palmitic Acid, Phytosteryl Canola Glycerides, Citric Acid, Stearic Acid, Stearic Acid, Tocopherol, Trolein, Bisabolol, Benzyl Salicylate, Citronellol and Hexyl Cinnamal.
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INGREDIENTS AND APPEARANCE
DAYSTAR SHADE SPF MOISTURIZING SUNSCREEN
homosalate, zinc oxide, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54997-056 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 ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 94 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) PEG-100 STEARATE (UNII: YD01N1999R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) ISOSTEARIC ACID (UNII: X33R8U0062) BENZYL ALCOHOL (UNII: LKG8494WBH) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) CAPRYLYL GLYCOL (UNII: 00YIU5438U) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) XANTHAN GUM (UNII: TTV12P4NEE) BENZOIC ACID (UNII: 8SKN0B0MIM) LINOLEIC ACID (UNII: 9KJL21T0QJ) PROPYLENE CARBONATE (UNII: 8D08K3S51E) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OLEIC ACID (UNII: 2UMI9U37CP) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) PALMITIC ACID (UNII: 2V16EO95H1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) LEVOMENOL (UNII: 24WE03BX2T) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54997-056-00 1 in 1 CARTON 06/07/2024 1 60 mL in 1 TUBE; 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 06/07/2024 Labeler - 4Life Research USA, LLC (618510226)