Label: LEADER SPORT SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 37205-725-64
- Packager: Cardinal Health
- 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 October 3, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- ASK DOCTOR
- Keep out of reach of children.
-
Directions
- Apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 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 sleeve shirts, pants, hats, and sunglasses
-
Children under 6 months: ask a doctor
-
Inactive Ingredients
water, styrene/acrylates copolymer, propylene glycol, neopentyl glycol diheptanoate, bis-stearyl ethylenediamine/neopentyl glycol/stearyl hydrogenated dimer dilinoleate copolymer, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, chlorphenesin, oleth-3, tocopherol (vitamin E), fragrance, disodium EDTA
- Other infomation
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LEADER SPORT SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-725 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 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 130 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) TROLAMINE (UNII: 9O3K93S3TK) CHLORPHENESIN (UNII: I670DAL4SZ) OLETH-3 (UNII: BQZ26235UC) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-725-64 237 mL in 1 CAN; Type 0: Not a Combination Product 01/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/15/2012 Labeler - Cardinal Health (097537435)
