Label: BLUE LIZARD ACTIVE SPF 50 SUNSCREEN- octisalate and titanium dioxide and zinc oxide lotion
- NDC Code(s): 0316-2072-30, 0316-2072-40, 0316-2072-45, 0316-2072-50
- Packager: Crown Laboratories
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 4, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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Uses
- Helps prevent sunburn and photodamage caused by UVA/UVB exposure
- Higher SPF gives more sunburn protection
- If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
• Shake well prior to use
• Apply liberally to dry skin 15 minutes before sun exposure
• For topical use only
• Children under 6 months: 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.
• Reapply to dry skin: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
- Other Information
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Inactive Ingredients
Alumina, Aluminum Stearate, Beeswax, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Capylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Diisopropyl Sebacate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Hexyl Laurate, Hydrogenated Castor Oil, Isostearyl Isostearate, L-Arginine, Methyl Glucose Dioleate, Methylpropanediol, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Phenylpropanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polyurethane-35, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer
- Questions?
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Blue Lizard Active 5oz Tube
BLUE LIZARD
AUSTRALIAN SUNSCREEN
50+
UVA/UVB PROTECTION
BROAD SPECTRUM
SPF 50+
TRAUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS
ACTIVE
mineral-based sunscreen
combining mineral and chemical UV protectors
Smart Cap TECHNOLOGY
CAP CHANGES COLOR IN HARMFUL UV LIGHT
WATER RESISTANT (80 MINUTES)
Mineral-Based Sunscreen
Combining mineral and chemical UV protectors for water-resistant performance you can trust.
P11863.00
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INGREDIENTS AND APPEARANCE
BLUE LIZARD ACTIVE SPF 50 SUNSCREEN
octisalate and titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-2072 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 55.5 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 59.5 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 111 mg in 1 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM STEARATE (UNII: U6XF9NP8HM) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) YELLOW WAX (UNII: 2ZA36H0S2V) ARGININE (UNII: 94ZLA3W45F) METHYLPROPANEDIOL (UNII: N8F53B3R4R) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYL LAURATE (UNII: 4CG9F9W01Q) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENYLPROPANOL (UNII: 0F897O3O4M) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) POLYURETHANE-35 (NOT MORE THAN 500 MPA.S AT 40%) (UNII: Q2LKX89BE0) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-2072-30 89 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2021 2 NDC:0316-2072-50 259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2021 3 NDC:0316-2072-45 148 mL in 1 TUBE; Type 0: Not a Combination Product 02/09/2021 4 NDC:0316-2072-40 1 in 1 CARTON 02/24/2021 4 148 mL in 1 BOTTLE, PLASTIC; 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 02/09/2021 Labeler - Crown Laboratories (079035945) Establishment Name Address ID/FEI Business Operations Crown Laboratories 079035945 manufacture(0316-2072)