Label: BLUE LIZARD SPORT SUNSCREEN- octocrylene and zinc oxide lotion
-
NDC Code(s):
0316-2021-10,
0316-2021-30,
0316-2021-40,
0316-2021-45, view more0316-2021-50, 0316-2021-60
- Packager: Crown Laboratories
- 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 February 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
-
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 risk of skin cancer and early skin aging caused by the sun
- Warnings
-
Directions
- Shake well prior to use
- Apply liberally to dry skin 15 minutes before sun exposure
- For topical use only
- Keep out of reach of children
- 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
-
Inactive Ingredients:
Beeswax, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyceryl-4 Isostearate, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer
- Questions?
-
Blue Lizard Sport 3oz Label
BLUE LIZARD
AUSTRALIAN SUNSCREEN
30+
UVA/UVB PROTECTION
BROAD SPECTRUM
SPF 30+
TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS
SPORT
mineral-based sunscreen
combining mineral and chemical UV protectors for water-resistance performance you can trust.
Smart Cap TECHNOLOGY
CAP CHANGES COLOR IN HARMFUL UV LIGHT
WATER RESISTANT (80 MINUTES)
P11449.02
-
INGREDIENTS AND APPEARANCE
BLUE LIZARD SPORT SUNSCREEN
octocrylene and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-2021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 41.8 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 104.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) ETHYLHEXYL PALMITATE (UNII: 2865993309) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) YELLOW WAX (UNII: 2ZA36H0S2V) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) STEARIC ACID (UNII: 4ELV7Z65AP) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) HEXYL LAURATE (UNII: 4CG9F9W01Q) METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P) PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5) EDETATE DISODIUM (UNII: 7FLD91C86K) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PROPANEDIOL (UNII: 5965N8W85T) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-2021-10 5 mL in 1 PACKET; Type 0: Not a Combination Product 01/02/2019 2 NDC:0316-2021-30 89 mL in 1 TUBE; Type 0: Not a Combination Product 01/02/2019 3 NDC:0316-2021-40 1 in 1 CARTON 01/02/2019 3 148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:0316-2021-50 259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/02/2019 5 NDC:0316-2021-60 3785 mL in 1 JUG; Type 0: Not a Combination Product 01/02/2019 01/31/2022 6 NDC:0316-2021-45 148 mL in 1 TUBE; Type 0: Not a Combination Product 01/02/2019 11/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/02/2019 Labeler - Crown Laboratories (079035945) Establishment Name Address ID/FEI Business Operations Crown Laboratories 079035945 manufacture(0316-2021)